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Behandlingstudier - Overblik Over Planlagte Og Igangværende Studier Af Lægemidler Til Behandling Af COVID-19
Behandlingstudier - Overblik Over Planlagte Og Igangværende Studier Af Lægemidler Til Behandling Af COVID-19
2020
Table of contents
Antiviral drugs .............................................................................................................................................................4
Remdesivir .........................................................................................................................................................4
Lopinavir + Ritonavir (Kaletra) ...........................................................................................................................7
Favipiravir (Avigan) ..........................................................................................................................................14
Darunavir + cobicistat or ritonavir ...................................................................................................................18
Umifenovir (Arbidol) ........................................................................................................................................19
Other antiviral drugs ........................................................................................................................................20
Antineoplastic and immunomodulating agents .......................................................................................................24
Convalescent Plasma ............................................................................................................................................24
Immunoglobulins..................................................................................................................................................46
Monoclonal antibodies.........................................................................................................................................47
Tocilizumab (RoActemra) alone or in combination with other drugs ..............................................................47
Sarilumab (Kevzara) .........................................................................................................................................54
Siltuximab (Sylvant) .........................................................................................................................................57
Bevacizumab (Avastin) .....................................................................................................................................58
Other monoclonal antibodies ..........................................................................................................................58
Interferons............................................................................................................................................................67
Protein kinase inhibitors ......................................................................................................................................71
Ruxolitinib (Jakavi) ...........................................................................................................................................71
Baricitinib (Olumiant) .......................................................................................................................................75
Other protein kinase inhibitors ........................................................................................................................76
Other immunomodulating drugs..........................................................................................................................78
Anti-inflammatory drugs ..........................................................................................................................................93
Leflunomide .....................................................................................................................................................93
Colchicine .........................................................................................................................................................94
Naproxen .........................................................................................................................................................97
Ibuprofen .........................................................................................................................................................97
Piclidenoson (CF101)........................................................................................................................................98
Glucocorticoids .........................................................................................................................................................98
Stem cell therapy ....................................................................................................................................................103
Cardiovascular drugs ..............................................................................................................................................118
Angiotensin receptor blocker or ACE inhibitor...................................................................................................118
Other ..................................................................................................................................................................122
Spironolactone ...............................................................................................................................................122
Amiodarone and Verapamil ...........................................................................................................................122
Prazosin ..........................................................................................................................................................122
Ifenprodil........................................................................................................................................................123
Atorvastatin ...................................................................................................................................................124
Blood and blood forming organs ............................................................................................................................124
Alteplase ........................................................................................................................................................124
Aspirin ............................................................................................................................................................124
Defibrotide .....................................................................................................................................................125
Tranexamic acid .............................................................................................................................................125
Tinzaparin.......................................................................................................................................................125
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Antitrombin....................................................................................................................................................126
Dipyridamidole ...............................................................................................................................................126
Dociparstat sodium ........................................................................................................................................127
Enoxaparin .....................................................................................................................................................127
Heparin ..........................................................................................................................................................131
Nafamostat ....................................................................................................................................................132
Ilomedin .........................................................................................................................................................132
Plasminogen Activator ...................................................................................................................................133
Prolongin ........................................................................................................................................................133
Ulinastatin ......................................................................................................................................................133
ACE-2 ......................................................................................................................................................................133
Angiotensin 1-7 .......................................................................................................................................................134
Chloroquine or hydroxychloroquine.......................................................................................................................135
Other drugs studied for the treatment or prevention of COVID-19 .......................................................................173
Alimentary tract and metabolism ......................................................................................................................173
Bismuth potassium citrate .............................................................................................................................173
Dapagliflozin ..................................................................................................................................................173
Famotidine .....................................................................................................................................................173
Linagliptin.......................................................................................................................................................174
Microbiota......................................................................................................................................................174
MRx-4DP0004 ................................................................................................................................................175
ResCure ..........................................................................................................................................................175
Probiotics .......................................................................................................................................................175
Sitagliptin .......................................................................................................................................................176
Vitamins and minerals ...................................................................................................................................176
Isotretinoin.....................................................................................................................................................182
Genito urinary system and sex hormones ..........................................................................................................183
Aviptadil .........................................................................................................................................................183
Progesterone..................................................................................................................................................183
Sildenafil.........................................................................................................................................................184
Other systemic hormonal preparations .............................................................................................................184
Triiodothyronine (T3) .....................................................................................................................................184
Estradiol Patch ...............................................................................................................................................184
Oxytocin .........................................................................................................................................................184
Other antiinfectives for systemic use .................................................................................................................184
Azithromycin ..................................................................................................................................................184
Clarithromycin................................................................................................................................................186
Doxycycline ....................................................................................................................................................186
Itraconazole ...................................................................................................................................................186
Kolimycin ........................................................................................................................................................186
Nervous system ..................................................................................................................................................186
Chloropromazine ...........................................................................................................................................186
1,3,7-Trimethylxanthine ................................................................................................................................187
Dexmedetomidine .........................................................................................................................................187
Fluvoxamine ...................................................................................................................................................187
Melatonin.......................................................................................................................................................187
Metenkefalin + Tridecactide ..........................................................................................................................188
Naltrexone and Ketamine ..............................................................................................................................188
Pyridostigmin .................................................................................................................................................188
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Sevoflurane ....................................................................................................................................................188
Vafidemstat, ...................................................................................................................................................188
Antiparasitic products, insecticides and repellents ............................................................................................189
Artesunate .....................................................................................................................................................189
Dihydroartemisinine piperaquine ..................................................................................................................189
Ivermectine ....................................................................................................................................................190
Suramin sodium .............................................................................................................................................196
Respiratory system .............................................................................................................................................196
Almitrine ........................................................................................................................................................196
Acetylcystein ..................................................................................................................................................196
Bromhexine ....................................................................................................................................................197
Dornase Alfa ...................................................................................................................................................197
Ebastine..........................................................................................................................................................198
Hydrogen-oxygen nebulizer ...........................................................................................................................198
Lucinactant.....................................................................................................................................................199
Montelukast ...................................................................................................................................................199
Nitrogen oxide ...............................................................................................................................................199
Nebulized amniotic fluid ................................................................................................................................201
Other ..................................................................................................................................................................203
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Antiviral drugs
Remdesivir
Nucleosid inhibitor, not licensed
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Remdesivir https://clinicaltrials.gov/ Hubei, China A Phase 3 Randomised, Double-blind, Time to Clinical Recovery defined as the Recruiting; High
ct2/show/NCT04252664 Placebo-controlled Multicenter Study time (in hours) from initiation of study Estimated study
Sponsor: Capital Medical ?cond=COVID- treatment (active or placebo) until completion: April 27,
University 19&draw=2&rank=1 N=308 hospitalized Adult Patients With normalisation of fever, respiratory rate, 2020
Mild and Moderate 2019-nCoV and oxygen saturation, and alleviation
NCT04252664 Respiratory Disease randomised to of cough, sustained for at least 72 Update 15.04.2020:
Remdesivir, or hours. Suspended (The
placebo epidemic of COVID-19
has been controlled
well at present, no
eligible patients can
be recruitted.)
Remdesivir https://clinicaltrials.gov/ Beijing, China A Phase 3 Randomised, Double-blind, Time to Clinical Improvement (TTCI), Terminated; High
ct2/show/NCT04257656 Placebo-controlled, Multicenter Study two steps in a Six-category ordinal
Sponsor: Capital Medical ?term=remdesivir&draw scale:1 (discharged) to 6 (death), Estimated study
University =2&rank=1 N= 453 Hospitalized Adult Patients With censoring at day 28 completion: May 1,
Severe 2019-nCoVRespiratory Disease 2020
ranomised to
NCT04257656 Remdesivir, or Update 15.04.2020:
placebo Terminated (The
epidemic of COVID-19
has been controlled
well in China, no
eligible patients can
be enrolled at
present.)
Update 30.04.2020
Results published in
Lancet
Remdesivir NCT04280705 Up to 50 sites Phase 3 Multicenter, Adaptive, Percentage of subjects reporting each Recruiting; High
globally; Randomised Blinded Controlled Trial severity rating on the 7-point ordinal
EudraCT number: 2020- Maryland, N=440 Hospitalized Adults with covid- scale (death – not hospitalized), Estimated primary
Sponsor: National Institute 001052-18 Nebraska, 19 randomised to timeframe day 15 completion: April
of Allergy and Infectious Texas, Remdesivir, or 2023
Diseases (NIAID) Washington,US; Placebo
Korea
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Denmark Update: at least 800 patients will be Update: 30.04.2020:
included Preliminary results
presented by NIAID
Remdesivir NCT04292730 China, France, Phase 3 open label randomised Proportion of participants in each group Recruiting; High
Germany, Hong controlled trial. discharged by day 14.
Sponsor: EudraCT number: Kong, Italy, N=600 1600 patients with moderate The Odds of Ratio for Improvement on Estimated primary
Gilead Sciences 2020-000841-15 Japan, Korea, covid-19 randomised 1:1:1 to a 7-point Ordinal Scale on Day 11 [ Time completion May 2020
Netherlands, Remdesivir 100 mg for 5 days, Frame: Day 11 ]
Simple trial Republic of Remdesivir 100 mg for 10 days, or
Singapore, standard of care
Spain, Sweden,
Taiwan, UK, US Extension of the study with more
patients
Remdesivir NCT04292899 China, France, Phase 3 open label randomised Proportion of Participants With Recruiting, High
Sponsor: Germany, Hong controlled trial. Normalization of Fever and Oxygen
Gilead Sciences EudraCT number: Kong, Italy, N=400 6000 patients with severe covid- Saturation Through Day 14 Estimated study
2020-000842-32 Japan, Korea, 19 randomised to Remdesivir 100 mg The Odds of Ratio for Improvement on completion May 2020
Simple trial Netherlands, for 5 days, or a 7-point Ordinal Scale on Day 14 [ Time
Republic of Remdesivir 100 mg for 10 days. Frame: Day 14 ] Update 30.04.2020:
Singapore, Preliminary results
Spain, Sweden, Extension of the study. More patients presented by Gilead
Taiwan, UK, US have been added and patients who are
mechanically ventilated are included
Remdesivir Early news: EU: France, Adaptive, randomised open clinical trial Subject clinical status (on a 7-point Recruiting; High
https://www.sciencema Spain, UK, to one of 4 treatments ordinal scale) on Day 15
g.org/news/2020/03/wh Germany, Estimated study
o-launches-global- Belgium, completion: March
megatrial-four-most- Netherlands, 2023
promising-coronavirus- Luxembourg,
treatments Norway, Italy
N=3200
WHO Solidarity and
Discovery ROW:
Argentina,
NCT04315948 Bahrain,
Canada, Iran,
Canada: NCT04330690 South Africa,
Switzerland and
Norway: 2020-000982- Thailand
18, NCT04321616
Spain: 2020-001366-11 More countries
are expected to
join. As of
March 27 2020,
over 70
countries have
5
Version of 16.06.2020
confirmed they
will contribute
to the trial
Remdesivir + Baricitinib Early news: Japan, Phase 3 Multicenter, Adaptive, Time to recovery [ Time Frame: Day 1 Recruiting High
https://www.niaid.nih.g Singapore, Randomized Blinded Controlled Trial of through Day 29 ]: Day of recovery is
Sponsor: National Institute ov/news-events/news- United Stated the Safety and Efficacy of defined as the first day on which the Estimated Primary
of Allergy and Infectious releases Investigational Therapeutics for the subject satisfies one of the following Completion Date:
Diseases (NIAID) Treatment of COVID-19 in Hospitalized three categories from the ordinal scale: August 1, 2023
NCT04401579 Adults (ACTT-II) 1) Not hospitalized, no limitations on
activities; 2) Not hospitalized, limitation
N=1032 adult admitted to a hospital on activities and/or requiring home
with symptoms suggestive of COVID-19 oxygen; 3) Hospitalized, not requiring
(PCR-confirmed). Illness severity supplemental oxygen and no longer
defined by at least 1 of 4 listed criteria. requires ongoing medical care.
Remdesivir NCT04323761 Louisiana, New Expanded Access Treatment Protocol: Not applicable Not applicable Medium
Expanded Access Jersey, New Remdesivir (RDV; GS-5734) for the
Amendment to study York Treatment of SARS-CoV2 (CoV)
Treatment IND/Protocol: NCT04292730 Infection
Allows a large, widespread
population access to a Inclusion criteria:
drug or biological product Hospitalized with confirmed SARS-CoV2
that has not been by polymerase chain reaction (PCR) or
approved by the FDA. This known contact of confirmed case with
type of expanded access syndrome consistent with coronavirus
can only be provided if the disease (COVID-19) with PCR pending
product is already being Requiring invasive mechanical
developed for marketing ventilation
for the same use as the
expanded access use.
Remdesivir NCT04302766 US Intermediate-Size Patient Population Not applicable Not applicable Medium
Expanded access Expanded Access Treatment Protocol
for COVID-19;
Sponsor: U.S. Army
Medical Research and Inclusion criteria: DoD-affiliated
Development Command personnel as defined in DoDI 6200.02,
which includes emergency-essential
civilian employees and/or contractor
personnel accompanying the Armed
Forces who are subject to the same
health risk as military personnel
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Remdesivir Eudract: 2020-001453- France Expanded Access Treatment Protocol: The incidence rate of treatment Ongoing Medium
49 Germany Remdesivir (RDV;GS-5734) for the emergent adverse events
Italy Treat-ment of SARS-CoV2 (CoV) Estimated primary
Sponsor: Gilead https://www.aifa.gov.it/ Spain Infection- COVID-19 completion.
web/guest/-/covid-19- Switzerland 10.10.2020
aifa-autorizza- United Kingdom Intubated adult patients with critically
programma-di-uso- COVID-19.
compassionevole-con-
remdesivir
https://www.aifa.gov.it/
documents/20142/1144
520/Remdesivir_docum
enti.zip
Remdesivir vs NCT04349410 US, California Open label randomized controlled trial. Improvement in FMTVDM Enrolling by invitation; Low
Hydroxychloroquine, N=500 patients with COVID-19 Measurement with nuclear imaging. [ Estimated Primary
Azithromycin vs Randomized into 1 of 11 treatment Time Frame: 72 hours ] Completion Date :
Hydroxychloroquine, arms October 11, 2020
Doxycycline vs FMTVDM: Fleming Method for Tissue
Hydroxychloroquine, and Vascular Differentiation and
Clindamycin vs Metabolism
Hydroxychloroquine,
Clindamycin, Primaquine -
low dose vs
Hydroxychloroquine,
Clindamycin, Primaquine -
high dose vs
Tocilizumab vs
Methylprednisolone vs
Interferon-Alpha2B vs
Losartan vs
Convalescent Serum
Remdesivir NCT04365725 France Retrospective cohort trial of the effects Clinical course on Day 15. [ Time Frame: Not yet recruiting Low
(multicenter) of Remdesivir in the treatment of 15 days ]
Sponsor: severe Covid-19 infections. Estimated primary
Assistance Publique - 25.04.2020
Hôpitaux de Paris N=200 subjects ≥ 18 years with
confirmed SARS-CoV-2 infection
Product Study identifier Study location Study design Primary outcome Status of trial Importance
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Lopinavir+ Ritonavir https://clinicaltrials.gov/ Tongji Hospital, Phase 4 single blinded, Prospective, Rate of disease remission (Time Frame: Recruiting; High
ct2/show/NCT04255017 Hubei, China Randomised Controlled Cohort Study to two weeks)
Sponsor: ?draw=2 Compare the Efficacy of Three Antiviral Estimated primary
Tongji Hospital Drugs (Abidol Hydrochloride Time for lung recovery (Time Frame: completion: June 1,
NCT04255017 (Umifenovir), Oseltamivir and two weeks) 2020
Lopinavir/Ritonavir) in the Treatment of
2019-nCoV Pneumonia.
More countries
are expected to
join
Lopinavir + Ritonavir in Early news: EU: France, Phase 2, adaptive, randomised open Subject clinical status (on a 7-point Recruiting; High
combination with https://www.sciencema Spain, UK, clinical trial to one of 4 treatments ordinal scale) on Day 15
Interferon-beta g.org/news/2020/03/wh Germany, Estimated study
o-launches-global- Belgium, completion: March
megatrial-four-most- Netherlands, 2023
promising-coronavirus- Luxembourg,
treatments Norway, Italy
N=3200
WHO Solidarity and
Discovery ROW:
Argentina,
NCT04315948 Bahrain,
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Canada, Iran,
NCT04330690 (Canadian South Africa,
arm) Switzerland and
Thailand
Spain: 2020-001366-11
More countries
are expected to
join
Lopinavir and ritonavir NCT04328285 France, angers, A 2-step randomized double-blind Occurrence of an symptomatic or Not yet recruiting; High
Paris, Saint placebo-controlled clinical trial. asymptomatic SARS-CoV-2 infection Estimated Primary
Etienne N=600 health care workers randomised among healthcare workers [ Time Completion:
to Lopinavir and ritonavir or placebo Frame: Up to 2.5 months ] November 30, 2020
Lopinavir/ritonavir NCT02735707 REMAP- USA, Global Platform trial, including 3 active arms Patients: community-acquired REMAP-CAP is ongoing High
Hydroxychloroquine CAP link with: pneumonia, including COVID-19 Estimated primary
Hydroxychloroquine + https://www.remapcap. patients, who require ICU care for the completion:
lopinavir/ritonavir org . Lopinavir/ritonavir, support of organ functions December 2021
Vs The trial protocol: Hydroxychloroquine, Outcome The primary endpoint for all
No intervention https://www.remapcap. Hydroxychloroquine + domains will be all-cause mortality at
org/protocol- lopinavir/ritonavir, or no intervention 90 days
documents The REMAP-CAP platform trial as a
whole will recruit app. 7000 patients
REMAP-CAP: from study sites across Asia-Pacific,
Randomized, Embedded, Europe and North America excluding
Multifactorial Adaptive US.
Platform trial for
Community-Acquired
Pneumonia
Lopinavir/ritonavir The trial is registered at: Australia, New RCT active control Patients with confirmed SARS-CoV-2 by Not yet recruiting High
ACTRN12620000445976 Zealand and Participants will be randomised in a nucleic acid testing in the past 12 days
Hydroxychloroquine across the 1:1:1:1 ratio to the standard of care or 3 Proportion of participants alive and not
world. treatment arms, having required intensive respiratory
support (invasive or non-invasive
ventilation or humidified high flow
nasal oxygen flow) at 15 days after
enrolment.
9
Version of 16.06.2020
Lopinavir-Ritonavir, NCT04381936 United Kingdom A phase 2/3 open-label randomized trial All-cause mortality [ Time Frame: Recruiting High
Hydroxychloroquine, investigating whether treatment with Within 28 days after randomisation ]
Corticosteroids, (RECOVERY) either Lopinavir-Ritonavir, Estimated Primary
Azithromycin, Tocilizumab Hydroxychloroquine, Corticosteroids, Completion Date:
Azithromycin or Tocilizumab prevents December 2020
Sponsor: University of death in patients with COVID-19
Oxford compared to standard care.
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Version of 16.06.2020
Interferon 1β vs Low-dose N=2000 hospitalised patients with Estimated primary
Corticosteroids vs EudraCT 2020-001113- covid-19 are randomised to 1 of 5 completion: 2030?
Hydroxychloroquine. 21 treatment arms in addition to usual
standard of care:
Sponsor: University of No additional treatment,
Oxford Lopinavir-Ritonavir,
Interferon 1β,
Low-dose Corticosteroids, or
Hydroxychloroquine.
Lopinavir + Ritonavir NCT04252885 Guangdong, Open label, The rate of virus inhibition Recruiting; Medium
Arbidol China 125 patients Randomised 2:2:1 to
Lopinavir /Ritonavir Tablets, Estimated primary
Sponsor: Guangzhou 8th Arbidol, or completion: May, 30 ,
People's Hospital ordinary treatment 2020
Lopinavir + Ritonavir NCT04261907 Zhejiang Randomised, Open-label, Multi-centre The incidence of composite adverse Recruiting (according Medium
University, Clinical Trial outcome (time frame 14 days) to Chinese website
Sponsor: First Affiliated China that was updated )
Hospital of Zhejiang http://www.chictr.org.c N=160 patients with pneumonia caused
University n/showproj.aspx?proj=4 by covid-19 randomised to Estimated primary
9075 ASC09/ritonavir or lopinavir/ritonavir completion: May 31,
2020
Lopinavir + Ritonavir ChiCTR2000029539 Tongji, Hubei, Open label study. The incidence of adverse outcome Recruiting; Medium
China within 14 days after admission: Patients
Sponsor: Tongji Hospital, http://www.chictr.org.c N=328 Patients with mild covid-19 or with conscious dyspnea, SpO2 = 94% or From2020-02-03 To
Tongji Medical College, n/showproj.aspx?proj=4 unexplained viral pneumonia respiratory frequency = 24 times / min 2021-02-02
Huazhong University of 8991 ChiCTR2000029603 randomised 1:1 to in the state of resting without oxygen
Science and Technology conventional standardized treatment + inhalation;
Lopinavir/Ritonavir, or
conventional standardized treatment
Lopinavir + Ritonavir vs NCT04286503 Beijing YouAn A Multicenter, Randomised, Open- Fever to normal time (day) (Time Not yet recruiting; Medium
Carrimycin; Hospital and controlled Study, Frame: 30 days)
ChiCTR2000029867 other hospitals Estimated study
Carrimycin is licenced in in China N=520 patients stratified by severity, Pulmonary inflammation resolution completion, Feb 28,
China Randomised 1:1 to time (HRCT) (day) (Time Frame: 30 2021
1) carrimycin or days)
2) lopinavir/ritonavir or arbidol or
Sponsor: Beijing YouAn chloroquine phosphate Negative conversion (%) of 2019-
Hospital nCOVRNA in gargle (throat swabs) at
the end of treatment (Time Frame: 30
days
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Version of 16.06.2020
Lopinavir + ritonavir NCT04321993 Canada Open label clinical trial. Clinical status of subject at day 15 (on a Not yet recruiting; Medium
Hydroxychloroquine N=1000 hospitalised patients with 7 point ordinal scale). Estimated Primary
sulfate moderate to severe COVID-19 Completion: February
Baricitinib (janus kinase randomised to 2021
inhibitor) Lopinavir + ritonavir,
Sarilumab (anti-IL-6 Hydroxychloroquine sulfate,
receptor) Baricitinib,
Sarilumabt, or
standard care
Lopinavir/ritonavir NCT04346147 Spain Prospective, Phase II, Randomized, Time to clinical improvement [ Time Active, not recruiting Medium
Imatinib tablets EudraCT: Open-label, Parallel Group Study to Frame: baseline to day 14 ]
Baricitinib Oral Tablet in 2020-001321-31 Evaluate the Efficacy of Estimated primary
combination with Hydroxychloroquine Together With completion: August
hydroxychloroquine Baricitinib, Imatinib or Early Lopinavir / 2020
Ritonavir in Patients With SARS Cov2
Sponsor: Hospital Pneumonia
Universitario de
Fuenlabrada N=165 randomized to receive open
treatment 1:1:1.
3 branches:
lopinavir / ritonavir (200 /50),
imatinib 400mg or
baricitinib 4mg, all in combination with
hydroxychloroquine 200mg,
administered for 7 days.
Lopinavir-Ritonavir, NCT04386070 Not stated Phase 3, randomized, open-label trial to Pneumonia free survival; acute Not yet recruiting Medium
Hydroxychloroquine reduce COVID-19 related pulmonary respiratory distress syndrome (ARDS)
2020-001448-24 complications in adult patients free survival; or death [ Time Frame: Estimated Primary
Sponsor: undergoing all types of elective or From randomisation until discharge Completion Date: May
University of Birmingham emergency surgery in a COVID-19 from hospital, average less than 30 days 14, 2021
exposed environment. ]
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Version of 16.06.2020
Lopinavir / ritonavir and ChiCTR2000031196 China, Beijing Nonrandomized study observing the Time till the SARS-CoV-2 clearance Recruiting Low
interferon antiviral efficacy and side effects of
Sponsor: Diagnosis, lopinavir / ritonavir tablets combined From 2020-01-10 To
treatment and Research with interferon 2020-12-31
Center for infectious
diseases, the fifth medical N = 90. 2:1 (treatment:control)
center of the PLA
Lopinavir + ritonavir ChiCTR2000029308 Hubei, China Open label, randomised trial. Clinical improvement time of 28 days Ongoing; Low
N=160 randomised to lopinavir + after randomization Duration: From2020-
ritonavir or conventional treatment 01-10 To 2021-01-10
Lopinavir + Ritonavir http://www.chictr.org.c Wuhan, China N=60 randomised to The rate of remission Not Recruiting; Low
n/showprojen.aspx?proj traditional Chinese medicine,
=48824 Lopinavir/ritonavir, or Estimated study
traditional Chinese medicine + completion: Dec 31,
ChiCTR2000002940 lopinavir/ritonavir 2020
Lopinavir + Ritonavir NCT04276688 Hong Kong Phase 2 study Time to negative nasopharyngeal swab completed; Low
Vs Open-label randomised controlled trial (NPS) 2019-n-CoV coronavirus viral RT-
Lopinavir + Ritonavir among adult patients hospitalized and PCR Estimated study
+ Ribavirin confirmed covid-19 infection completion: July 31,
+ interferon beta1b 2022
N=70 hospitalised patients with
confirmed covid 19 infection Update: 05.05.2020:
randomised to Study completed
Lopinavir/ritonavir or March 30, 2020; no
Lopinavir + Ritonavir results posted yet;
+ Ribavirin 127 patients recruited
+ interferon beta1b
Lopinavir + Ritonavir + ChiCTR2000029387 Chongqing, N= 108 patients with mild or moderate The time to 2019-nCoV RNA negativity Recruiting Low
interferon +/- ribavirin China covid-19 randomised to in patients; Study execute time:
http://www.chictr.org.c Ribavirin + Interferon alpha-1b, From 2020-01-25 to
Sponsor: n/showproj.aspx?proj=4 lopinavir / ritonavir + interferon alpha- 2021-01-25
The University of Hong 8782 1b, or
Kong Ribavirin + LPV/r+Interferon alpha-1b;
Link to study protocol:
https://www.ncbi.nlm.ni
h.gov/research/coronavi
rus/publication/3214977
2
Lopinavir + Ritonavir ChiCTR2000030187 Hubei, China N=60 randomised to lopinavir/ritonavir, Endotracheal intubation rate, time Not yet recruiting; Low
http://www.chictr.org.c or frame: 14 days
n/showproj.aspx?proj=5 Routine symptomatic support Mortality, time frame: 14 days From2020-02-25 To
0057 treatment 2020-03-10
13
Version of 16.06.2020
Lopinavir + Ritonavir vs NCT04307693 Seoul, Republic Multicenter, open labelled, randomized Viral load (Time Frame 18 days) Recruiting; Low
Hydroxychloroquine of Korea clinical trial Estimated study
N=150 with mild covid-19 completion: May 2020
Randomised to
Lopinavir/Ritonavir,
Hydroxychloroquine, or
Conventional treatment
Lopinavir + Ritonavir vs ChiCTR2000029759 Chongqing A multicenter, randomised, open label, Time to recovery. From2020-02-15 To Low
Arbidol vs ASC09/ http://www.chictr.org.c controlled trial 2020-05-01
Ritonavir (ASC09F) n/showproj.aspx?proj=4 60 patients randomised to
9352
Lopinavir / Ritonavir (Kaletra) + IFN
aerosol inhalation,
Abidol and IFN aerosol inhalation, or
ASC09/ Ritonavir (ASC09F) and IFN
aerosol inhalation
Lopinavir + Ritonavir + ChiCTR2000029468 Sichuan, China Single arm study with historical controls Patient survival rate Not yet recruiting; Low
emtritabine /Tenofovir Patients with covid-19
alafenamide fumarate http://www.chictr.org.c N=60 in the intervention arm From 2020-02-01 To
n/showproj.aspx?proj=4 N=60 historical controls 2020-06-30
8919
Lopinavir + Ritonavir vs ChiCTR2000030218 Jiangxi, China Randomised trial, blinding not stated; Clinical recovery time; Recruiting; Low
pinavir + ritonavir vs http://www.chictr.org.c N=80 with mild or moderate covid-19 Pneumonia Severity Index (PSI) score
ritonavir n/showproj.aspx?proj=5 treated with From2020-01-22 To
0115 Pinavir / ritonavir tablets combined 2020-06-25
with Xiyanping injection, or
Ritonavir, or
Lopinavir/ritonavir combined with
Xiyanping injection
Lopinavir/Ritonavir NCT04386876 Turkey A phase 1, randomized, open-label 1.Primary PK End Points [ Time Frame: Active, not recruiting Low
study to assess the bioequivalence of 12 weeks ] Estimated Primary
Sponsor: World Medicine Orvical 200 mg/50 mg FT in comparison AUC0-tlast of lopinavir and ritonavir Completion Date: May
ILAC SAN. ve TIC. A.S. with kaletra 200 mg/50 mg FT 2.Primary PK End Points [ Time Frame: 22, 2020
13 weeks ]
N = 30 healthy male subjects under Cmax of lopinavir and ritonavir
fasting conditions testing two different
fixed combinatinos of lipinavir and
ritonavir
Favipiravir (Avigan)
T-705 or favilavir; experimental antiviral drug. Pyrazinecarboxamide derivative viral RNA polymerase inhibitor; Licenced for influenza in Japan
Product Study identifier Study location Study design Primary outcome Status of trial Importance
14
Version of 16.06.2020
Favipiravir EudraCT: 2020-001115- Milano, Italy A Multi-center, Randomized, Double- Time from randomization to clinical Active, not recruiting; High
Sponsor: ASST 25 blind, Placebo-controlled, Phase III recovery [Time Frame: 90 days] Estimated Primary
Fatebenefratelli Sacco NCT04336904 Clinical Study. Completion: July 2020
HS216C17 N=256 patients (of these at least 100
from Italy) with moderate COVID-19
randomised (1:1) to favipiravir or
placebo.
16 sites (of which 8 planned in Italy).
Favipiravir NCT04402203 Bangladesh Phase 2/3, double-blind, placebo- 1. Number of participants negative by Recruiting Medium
controlled randomized control study on RT-PCR for the virus at 4-10 days after
Sponsor: the safety and efficacy of Favipiravir for initiation of therapy. [ Time Frame: at 4 Estimated Primary
Bangladesh Medical COVID-19 patients in selected hospitals to 10 days of therapy ] Completion Date: July
Research Council (BMRC) of Bangladesh 2020
2. Number of participants with lung
N=50 randomized 1:1 to Favipiravir + condition change assessed with X-ray. [
Standard Treatment or Standard Time Frame: at Day-4, Day-7 and Day-
Treatment alone. 10 of therapy ]
Favipiravir http://www.chictr.org.c Zhejiang, China N=30, Randomised 1:1:1 to Primary outcome: time to negative PCR Not recruiting; Medium
n/showprojen.aspx?proj BaloxavirMarboxil, and time to clinical improvement
=49015 Favipiravir, or Estimated study
Lopinavir-Roitonavir; completion: June 03
ChiCTR2000029548 ritonavir 2020
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Version of 16.06.2020
Favipiravir + Tocilizumab NCT04310228 Anhui, Open label randomised controlled trial Clinical cure rate [ Time Frame: 3 Recruiting Medium
Sponsor: Peking University ChiCTR2000030894 Beijing, N=150 randomised to months ]
First Hospital Hubei, China Randomized to Estimated Primary
favipiravir + tocilizumab (n=90) completion: May 2020
Favipiravir (n=30)
Tocilizumab (n=30) Duration: from 2020-
03-01 to 2020-05-31
Favipiravir NCT04349241 Egypt Phase 3 randomized controlled open- Viral clearance [Time Frame: 14 days] Not yet recruiting Medium
label placebo controlled clinical trial to
Sponsor: Ain Shams evaluate the Efficacy and Safety of Estimated primary
University Favipiravir in Management of COVID- Completion Date:
19. October 1, 2020
N=40 randomized to
Favipiravir+Hydroxychloroquine or
Hydroxychloroquine only.
Favipiravir, NCT04373733 United Kingdom Phase 3, randomized, open-label Time to improvement by two points on Not yet recruiting Medium
Hydroxychloroquine, (multiple sites) controlled trial of early intervention in a seven-category ordinal scale [ Time
Azithromycin 2020-001449-38 patients hospItalised with COVID-19. Frame: Up to 28 days from Estimated Study
randomisation Completion Date:
Sponsor: N=450 randomized 1:1:1 to March 31, 2021
Chelsea and Westminster hydroxychloroquine + azithromycin +
NHS Foundation Trust zinc + standard medical care or
favipiravir + standard medical care or
standard medical care alone.
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Version of 16.06.2020
Favipiravir NCT04358549 United States, Open Label, Randomized, Controlled Time to viral clearance [ Time Frame: Recruiting Low
Sponsor: Massachusetts Phase 2 Proof-of-Concept Study. Day 29 ] Estimated primary
Fujifilm Pharmaceuticals N=50 hospitalised paptients with completion: August
U.S.A., Inc. COVID-10randomised to favipiravir or 2020
standard of care
Favipiravir NCT04407000 Turkey Phase 1 Open-label,Randomised,Single Primary PK End Points AUC0-tlast [ Time Not yet recruiting Low
Oral Dose,Two-period,Cross-over Trial Frame: 12 weeks ]
Sponsor: to Assess to Bioequivalence. Estimated Primary
World Medicine ILAC SAN. Primary PK End Points Cmax [ Time Completion Date: June
ve TIC. A.S. N=18 healthy aged 20 to 40, with 2 Frame: 13 weeks ] 22, 2020
negative COVID-19 tests and non-
smokers.
Favipiravir, Kaletra, NCT04376814 Iran Randomized, open-label, multicenter Admission to the ICU [ Time Frame: Up Enrolling by invitation Low
Hydroxychloroquine study to evaluate the safety and to 28 days ]
efficacy of Hydroxychloroquine + Actual Primary
Sponsor: Favipiravir vs. Hydroxychloroquine + Completion Date:
Baqiyatallah Medical Kaletra on the need for intensive care April 5, 2020
Sciences University unit treatment in COVID-19 patients.
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Version of 16.06.2020
Favipiravir NCT04346628 United States, Phase 2, randomized, open label study Time until cessation of oral shedding of Not yet recruiting Low
California of oral favipiravir compared to standard SARS-CoV-2 virus [ Time Frame: Up to
Sponsor: supportive care in subjects with mild 28 days ] Estimated Primary
Stanford University COVID-19 Time in days from randomization to a Completion Date:
negative result of nasopharyngeal April 2021
N=120 randomized to favipiravir + and/or oropharyngeal and/or salivary
standard of care or standard of care swab.
alone
Favipiravir http://www.chictr.org.c Guangdong, N=30 with corona pneumonia with Blood routine tests, Liver function Recruiting; Low
n/showprojen.aspx?proj China poorly responsive ritonavir examination, Renal function
=49988 Randomised to ritonavir or favipiravir examination, Blood gas analysis, Chest Estimated study
CT examination completion: May 31,
ChiCTR2000030113 2020
Fapilavir ChiCTR2000029996 Beijing, China Randomised, open label, controlled Time to Clinical Recovery defined as Recruiting Low
Approved by China for http://www.chictr.org.c trial. normal body temperature and cough
covid-19 treatment by n/showproj.aspx?proj=4 N=60 patients with covid-19 of ordinary relief Estimated study
February 17, 2020. 9510 type randomised to low, middle or high completion: April 20,
dose fapilavir for 10 days 2020
Farpiravir ChiCTR2000030254 Hubei, China Randomised, open label, controlled Pulse oxygen saturation, Recruiting; Low
http://www.chictr.org.c trial. Respiratory support,
n/showproj.aspx?proj=5 N=240 with covid-19 randomised to nucleic acid test of novel coronavirus From2020-02-20 To
0137 farpiravir or 2020-03-20
abidole
Favipiravir NCT04333589 Anhui, Hubei, Open label randomised controlled trial Viral nucleic acid test negative Not yet recruiting; Low
Sponsor: Peking University Zhejiang N=210 patients who have cleared the conversion rate [ Time Frame: 5 months Estimated Primary
First Hospital China virus randomised to ] Completion: June 1,
Favipiravir, or 2020
Standard of care
18
Version of 16.06.2020
Active comparator: no intervention
Darunavir + Cobicistat ChiCTR2000029541 Hubei, China Randomised, open label study Time to conversion of 2019-nCoV RNA Dec 01, 2020 Low
result from RI sample
http://www.chictr.org.c N=100 patients with covid-19
n/showprojen.aspx?proj randomised to darunavir/cobicistat,
=48992 lopinavir/ritonavir combined, or
conventional treatment
Darunavir + Cobicistat NCT04252274 China, Shanghai Phase 3, randomised, open label The virological clearance rate of throat Recruiting; Low
swabs, sputum, or lower respiratory Estimated primary
Sponsor: N=30 patients with covid-19 tract secretions at day 7 [ Time Frame: 7 completion: August
Shanghai Public Health randomised to days after randomization ] 31, 2020
Clinical Center Darunavir and Cobicistat or
Conventional treatment
Danorevir+ritonavir ChiCTR2000031734 China, Hubei Open-label, controlled trial to evaluate Rate of composite advers outcomes: Recruiting Low
efficacy and safety of Danoprevir SpO2, PaO2/FiO2, respiratory rate
Sponsor: (Ganovo) combined with Ritonavir in From 2020-03-18 To
Huoshenshan Hospital, the treatment of light common type 2020-05-29
China, Hubei COVID-19.
N=40
Umifenovir (Arbidol)
An antiviral drug for influenza used in Russia and China
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Umifenovir ChiCTR2000029592 Hubei China Post exposure prophylaxis 2019-nCoV RNA;2019-nCoV Not yet recruiting; Medium
http://www.chictr.org.c Observational study antibody;Chest CT;
Sponsor: n/showproj.aspx?proj=4 From2020-02-05 To
Union Hospital, Tongji 9069 High-risk population including medical 2020-08-31
Medical College, Huazhong staff on duty during the outbreak of
University of Science and 2019-nCoV.
Technology N=1000
2 cohorts treated with Arbidol or no
Arbidol
Umifenovir NCT04350684 Tehran, Islamic A Randomized, Double-Blind, Placebo- Time to clinical improvement on a 7- Enrolling by invitation; Medium
+ Interferon Beta-1a + Republic of Iran Controlled, Clinical Trial point scale [ Time Frame: From date of Estimated Primary
lopinariv/ritonavir + randomization until 14 days later. ] Completion: April 22,
hydroxychloroquine N=40 patients with moderate to severe 2020
COVID-19 randomised to umifenovir +
Sponsor: interferon Beta-1a + lopinavir/ritonavir
Shahid Beheshti University + hydroxychloroquine, or
of Medical Sciences interferon Beta-1a + lopinavir/ritonavir
+ hydroxychloroquine
19
Version of 16.06.2020
Umifenovir http://apps.who.int/trial Xiangya Phase 4 Mortality (time frame 28 days) Not yet recruiting Low
search/Trial2.aspx?TrialI Hospital of A Randomised Multicenter Controlled
D=NCT04246242 Central South Clinical Trial
University N=500 with covid-19 infection
randomised to 200 mg, 400 mg or
conventional treatment
Umifenovir + interferon NCT04254874 Tongji Hospital, Phase 4 Open, Prospective, Randomised Rate of disease remission (Time Frame: Not yet recruiting; Low
(PegIFN-α-2b) China Controlled Cohort Study two weeks) Estimated study
completion date: July
N=100 randomised to Time for lung recovery (Time Frame: 1, 2020
arbidol Hydrochloride (Umifenovir), or two weeks)
Arbidol Hydrochloride Combined With
Interferon Atomization
Umifenovir ChiCTR2000029621 Shanghai, China Multicenter, randomised, open-label, Virus negative conversion rate in the Recruiting; Low
controlled trial first week
http://www.chictr.org.c N= 380 patients with mild or moderate From2020-01-01 To
n/showproj.aspx?proj=4 covid-19 2020-12-31
9165
Umifenovir, Novaferon, ChiCTR2000029573 Zhejiang, China N=600 randomised 1:1:1:1:1:1: to 2019-nCoV nucleic acid test confirmed Not yet recruiting Low
lopinavir/ritonavir arbidol, negative; From2020-02-05 To
http://www.chictr.org.c Novaferon + arbidol, 2020-06-30
n/showproj.aspx?proj=4 Lopinavir/ritonavir,
9065 Arbidol,
Novaferon, lopinavir/ritonavir, or
Novaferon + arbidol
Umifenovir NCT04260594 Jieming QU, Phase 4, Randomised, Open, Virus negative conversion rate in the Not recruiting yet; Low
Ruijin Hospital Multicenter Study first week
Estimated primary
N=380 with covid-19 randomised to completion date:July
arbidol or basic treatment 1, 2020
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Emtricitabine/tenofovir NCT04334928 Madrid, Spain Double blinded placebo-controlled trial. Number of confirmed symptomatic Recruiting; High
disoproxil vs N=4000 healthcare personnel infections of SARS-CoV-2 (COVID-19) [ Estimated Primary
Hydroxychloroquine (EPICOS) randomised to Time Frame: 12 weeks ] Completion: June 30,
Emtricitabine/tenofovir disoproxil + 2020
hydroxychloroquine,
Emtricitabine/tenofovir disoproxil +
placebo,
Hydroxychloroquine + placebo, or
Placebo + placebo.
Emtricitabine/Tenofovir NCT04405271 Argentina Phase 3, randomized, double-blind, COVID-19 incident cases [ Time Frame: Not yet recruiting High
Alafenamide (FTC/TAF) placebo-controlled trial of FTC/TAF for During treatment (12 weeks) ]
CoviPrep Study pre-exposure prophylaxis of COVID-19 Estimated Primary
Sponsor: in healthcare workers with high Completion Date:
Hospital Italiano de transmission risk in addition to November 15, 2020
Buenos Aires currently recommended control
measures.
21
Version of 16.06.2020
Lopipinavir/ Ritonavir Plus Oseltamivir,
Lopipinavir/ Ritonavir Plus Favipiravir,
or
Conventional qurantine
22
Version of 16.06.2020
Novaferon ChiCTR2000029496 Huhan, China Randomised controlled trial. Time to negative testing Recruiting; Low
New antiviral drug N=90 with covid-19 randomised to
developed in China http://www.chictr.org.c Novaferon, From2020-01-10To
n/showproj.aspx?proj=4 Kaletra, or 2021-01-10
8809 Novaferon+ Kaletra
DAS181 for compassionate NCT04324489 China, Hubei Single group assignment, Improved clinical status Completed; Low
use. N=4 with4severe COVID-19
Currently investigated for Update: Completed as
the treatment of of April 16, 2020
parainfluenzavirus
infection
Danoprevir + ritonavir ChiCTR2000030259 Shanghai Randomised, open label controlled trial. Rate of composite advers outcomes: Recruiting; Low
http://www.chictr.org.c N=60 patients with mild and moderate SpO2, PaO2/FiO2, respiratory rate From2020-02-22 To
n/showproj.aspx?proj=4 covid-19 randomised to Danorevir or 2020-04-30
9918 Symptomatic treatment
Danoprevir + Ritonavir NCT04345276 China, Hubei Phase 4, open-label, single-armed trial. Rate of composite adverse outcomes [ Recruiting Low
Time Frame: Within 10 days after
Sponsor: N=40 hospitalized patients infected administration ] Estimated Primary
Huoshenshan Hospital with SARS-CoV-2. Defined as SPO2≤ 93% without oxygen Completion Date:
supplementation, PaO2/FiO2 ≤ April 30, 2020
Danoprevir (100mg, one tablet each 300mmHg or a respiratory rate ≥30
time, twice per day, up to 10 days) + breaths per min without supplemental
Ritonavir (100mg, one tablet each time, oxygen min without supplemental
twice per day, up to 10 days). oxygen
EIDD-2801 NCT04392219 United States Phase 1, randomized, double-blind, 1. Safety and Tolerability of Single Recruiting Low
(Florida, Texas, placebo-controlled, first-in-human Ascending Dose (SAD) of EIDD-2801
2020-001407-17 Wisconsin) study to evaluate the safety, tolerability (Part 1): Adverse Events [ Time Frame: Estimated Primary
EIDD-2801 is a direct and pharmacokinetics of EIDD-2801. From screening through study Completion Date: June
acting anti-viral nucleoside EIDD-2801-1001 United Kingdom completion, up to 15 days ] 16, 2020
analogue N=122 (age 18-60 years) healthy
volunteers. 2. Safety and Tolerability of Multiple
Sponsor: Ascending Dose (MAD) of EIDD-2801
Ridgeback Biotherapeutics, Part 1: Subjects will be randomized to (Part 3): Adverse Events [ Time Frame:
LP receive a single oral dose of EIDD-2801 From screening through study
or Placebo. completion, up to 20 days ]
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Version of 16.06.2020
EIDD-2801 NCT04405570 United States Phase IIa Randomized, Double-Blind, Virologic Efficacy [ Time Frame: 28 days Not yet recruiting Medium
Placebo-Controlled Trial to Evaluate the ]
Sponsor: Ridgeback Safety, Tolerability and Efficacy of EIDD- Estimated Primary
Biotherapeutics, LP 2801 to Eliminate Infectious Virus Number of Participants with any Completion Date: June
Detection in Persons With COVID-19. Adverse Events (AEs) as Assessed by 24, 2020
Kaplan Meier Approach [ Time Frame:
N=44 adults randomized to 200 mg oral 28 days ]
capsule EIDD-2801 or Placebo.
EIDD-2801 NCT04405739 United States Phase 2 Randomized, Double-Blind, Number of Participants that achieve Not yet recruiting Medium
Placebo-Controlled Study of the Efficacy Virologic Clearance after oral
Sponsor: Ridgeback and Safety of EIDD-2801 on SARS-CoV-2 administration of EIDD-2801 [ Time Estimated Primary
Biotherapeutics, LP Virus Shedding in Newly Hospitalized Frame: 28 days ] Completion Date: June
Adults With PCR-Confirmed COVID-19 Number of Participants With any 24, 2020
Serious Adverse Events(SAEs) as
N=80 adults with condirmed COVID-19 assessed by CTCAEv4 [ Time Frame: 28
and former good health. Randomized to days ]
200 mg EIDD-2801, 300 mg EIDD-2801 Number of Participants With any
or placebo. Adverse Events(AEs) as assessed by
CTCAEv4 [ Time Frame: 28 days ]
Virazole NCT04356677 Not stated Phase 1, open label, non-randomized, Change in the clinical status severity Not yet recruiting Low
(ribavirin) two-arm interventional clinical trial to (CSS) rating from the first dose date up
Sponsor: Bausch Health evaluate the safety and efficacy of to the completion of treatment [ Time Estimated Study
Americas, Inc. Virazole (50 mg/mL or 100 mg/mL) Frame: 7 days ] Completion Date:
April 2021
N = 50 hospitalized adult patients who
have tested positive for COVID-19 and
have significant respiratory distress
LL-37 antiviral peptide ChiCTR2000030939 Beijing, Hubei Single arm study. Preliminary Several primary outcome measures: eg. Recruiting; Estimated Low
(CAS001) evaluation of the safety and efficacy of nuclear acid test of faeces, nuclear acid duration: 2020-03-
oral LL-37 antiviral peptide (CAS001) in test of the upper respiratory tract, IgM 16To 2020-10-01
the treatment of novel coronavirus etc
pneumonia (COVID-19). N=10
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Version of 16.06.2020
Human Coronavirus NCT04323800 Not stated yet Prevention study Cumulative incidence of composite Not yet recruiting; High
Immune Plasma A Randomized, Blinded Phase 2 Study, outcome of disease severity [ Time Estimated Primary
double-blinded randomised trial. Frame: Day 28]: Completion:
Sponsor: Sidney Kimmel N=150 participants defined as Close Death; December 31, 2022
Comprehensive Cancer contact exposure to person with COVID- Requiring mechanical ventilation and/or
Center at Johns Hopkins 19 within 96 hours of enrolment. in ICU;
Participants will be randomised to Anti- non-ICU hospitalization, requiring
SARS-coV-2 plasma or SARS-CoV-2 non- supplemental oxygen;
immune Plasma non-ICU hospitalization, not requiring
supplemental oxygen;
Not hospitalized, but with clinical and
laboratory evidence of COVID-19
infection;
Not hospitalized, no clinical evidence of
COVID-19 infection, but with positive
PCR for SARS-CoV-2
Convalescent Plasma NCT04355767 United States, Randomised, double blind, placebo- Time to disease progression [ Time Not yet recruiting; High
California controlled trial. Frame: 15 days ] Estimated Primary
N=206 patients with COVID-19, not Completion Date:
hospitalised, randomised to December 2022
Convalescent Plasma or placebo
Convalescent plasma NCT04362176 United States, Phase 3, randomized, blinded, placebo- COVID Ordinal Outcomes Scale:Day 15 [ Recruiting High
Tennessee controlled trial to test the safety and Time Frame: Study Day
Sponsor: efficacy of convalescent donor plasma Estimated Primary
Vanderbilt University to treat COVID-19 in hospitalized adults. Completion Date:
Medical Center April 2021
N=500 hospitalized covid-19 patients
≥18 with acute respiratory infection
randomized 1:1 to convalescent plasma
or placebo (lactated Ringer's solution
with multivitamins).
Convalescent Plasma NCT04364737 United States, A phase 2, randomized, double-blinded, Percentage of subjects reporting each Recruiting High
New York placebo-controlled trial to assess the severity rating on WHO ordinal scale for
Sponsor: Albert Einstein efficacy and safety of anti-SARS-CoV-2 clinical improvement [ Time Frame: 14 Estimated Study
College of Medicine convalescent plasma days post randomization ] Completion Date:
April 30, 2023
N = 300 hospitalized patients with acute
respiratory symptoms requiring oxygen
supplementation.
Convalescent plasma NCT04373460 United States? A phase 2, randomized, double-blind, 1.Cumulative incidence of Not yet recruiting High
controlled trial to evaluate the efficacy hospitalization or death prior to
Sponsor: Johns Hopkins of treatment with human coronavirus hospitalization [ Time Frame: Up to day Estimated Study
University immune plasma (HCIP) in reducing 28 ] Completion Date:
hospitalization and death prior to 2.Cumulative incidence of treatment- January 31, 2023
hospitalization among outpatient adults related serious adverse events [ Time
Frame: Up to day 28 ]
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Version of 16.06.2020
N = 1344 eligible subjects stratified 3.Cumulative incidence of treatment-
50:50 in the <65 vs > 65 age range related grade 3 or higher adverse
randomized in a 1:1 ratio to receive events [ Time Frame: Up to day 90 ]
either HCIP or control plasma.
Convalescent Plasma NCT04381858 Mexico Phase 3, Randomized, Controlled 1.Mean hospitalization time [Time Recruiting High
clinical trial to assess the safety and Frame: Through study completion, an
Sponsor: Centenario efficacy of the administration of average of 3 months] Estimated Primary
Hospital Miguel Hidalgo Convalescent plasma vs human 2.Mean Oxigenation index evolution Completion Date:
immunoglobulin in critically ill patients [Time Frame: Through study August 30, 2020
with COVID-19 infection. completion, an average of 3 months]
3.Rate of severe ARDS [Time Frame:
N = 500 hospitalized patients age 16 to Through study completion, an average
90 years with PCR confirmed SARS-CoV- of 3 months]
2 to 400 mL infusion of plasma from 4.Rate and time to dead [Time Frame:
COVID-19 convalescent patient. Through study completion, an average
of 3 months]
5.Mean time with invasive mechanical
ventilation [ Time Frame: Through study
completion, an average of 3 months ]
Convalescent Plasma NCT04383535 Not stated A randomized, double-blind, placebo- Clinical status during follow-up at 30th Not yet recruiting High
controlled clinical trial of convalescent day [ Time Frame: 30th Day since study
Sponsor: Hospital Italiano SARS COVID-19 plasma versus placebo preparation infusion (Placebo or Estimated Primary
de Buenos Aires to evaluate the effect between arms. Convalescent SARS COVID-19 plasma) ] Completion Date: July
15, 2020
N = 333 COVID-19 patients randomized
2:1 (222 plasma 111 placebo)
Convalescent Plasma NCT04390503 United States, A phase 2, double-blinded, placebo- Rate of Severe Disease [ Time Frame: Recruiting High
New York controlled, randomized control trial to Up to 28 days ]
Sponsor: Columbia assess the efficacy and safety of anti- Estimated Primary
University SARS-CoV-2 convalescent plasma Completion Date:
compared to control. April 2021
26
Version of 16.06.2020
Grupo Mexicano para el N=80 randomized to convalescent
Estudio de la Medicina plasma or placebo.
Intensiva
Convalescent Plasma NCT04415086 Brazil Phase 2, multicentre, randomized, Time elapsed until clinical improvement Recruiting Medium
open-label controlled study to evaluate or hospital discharge
Sponsor: COOPCOVID-19 the efficacy and safety of convalescent [ Time Frame: Follow up until 28 days Estimated Primary
University of Sao Paulo plasma in treatment of severe cases of after transfusion ] Completion Date:
General Hospital COVID-19. April 20, 2022
27
Version of 16.06.2020
addition to standard care or standard
care alone.
Convalescent plasma and NCT04395170 N/A Phase 2/3, randomized, open-label, Admission to ICU and/or mechanical Not yet recruiting Medium
anti-COVID-19 human multicenter, three-arm clinical trial to ventilation [Time Frame: One year]
immunoglobulin study the efficacy and safety of passive Estimated Primary
immunotherapy (convalescent plasma Completion Date:
Sponsor: Lifefactors Zona and anti-COVID-19 human December 2020
Franca, SAS immunoglobulin) compared to the
standard treatment in Colombia.
Convalescent Plasma NCT04391101 Not stated Phase 3, open label, parallel, Intrahospital mortality from any cause [ Not yet recruiting Medium
randomized clinical trial to determine Time Frame: Up to 28 days ]
Sponsor: the efficacy of convalescent plasma for Estimated Primary
Hospital San Vicente the treatment of severe COVID-19 Completion Date: June
Fundación infection in terms of decreased in- 2021
hospital mortality.
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Version of 16.06.2020
resolution of symptoms at least 28 days Time it takes the plasma collection
prior to donation. center to contact willing donors whom
are allowed to donate plasma
N=240 (plasma receipient)
Any age above 30 days of life, 3. Plasma Recipient [ Time Frame:
laboratory confirmed COVID-19, severe Measured evey 24 hours up to 30 days ]
or immediately life-threatening COVID- Time from consent to infusion
19
Mild Severity: standard of care - will not 4. Plasma Recipient [ Time Frame:
receive plasma unless there is Measured in days with 30 day from
progression of illness into the discharge follow-up ]
moderate/rapid progression or greater Survival
category
Moderate Severity: Convalescent
Plasma 1 Unit
Severe or Critical Severity: Convalescent
Plasma 2 Units
Convalescent plasma NCT04353206 United States, Phase 1, open-label trial on the 1. Proportion of subjects who consent Not yet recruiting Medium
California, feasibility of using convalescent plasma to the study and receive at least one
Sponsor: Noah Merin Maryland, in ICU patients dose of convalescent plasma. Estimated Primary
Pennsylvania Completion: May 2021
N = 90, Mechanically Ventilated 2. Overall survival of patients in the ICU
Intubated Patients With Respiratory receiving at least once dose of
Failure Due to COVID-19, receiving convalescent plasma for Covid-19-
multiple doses induced respiratory failure. [Time
Frame: 60 days]
Convalescent Plasma NCT04366245 Spain Phase 1/2, randomized, open-label trial 1. Safety: Incidence of Adverse Events Recruiting Medium
(multicentre) to evaluate the efficacy of treatment and Serious Adverse Events grade 3 and
Sponsor: with hyperimmune plasma obtained 4, related to the product under Estimated Study
Andalusian Network for from convalescent antibodies of COVID- investigation or the administration Completion Date:
Design and Translation of 19 infection. procedure, graduated according to the December 2021
Advanced Therapies common toxicity criteria scale (CTCAE).
N=72 randomized to plasma of [ Time Frame: 30 days after enrollment
convalescent covid-19 or ]
Hidroxicloroquina + Azitromicina o
Lopinavir/ritonavir + Interferon β-1b + 2. Efficacy: Death from any cause [ Time
Hidroxicloroquina Frame: Day +21 after randomization ]
29
Version of 16.06.2020
randomization. [ Time Frame: Day +21
after randomization ]
Convalescent plasma NCT04358783 Mexico Phase 2, double-blinded, controlled, Early all-cause mortality [Time Frame: Not yet recruiting Medium
randomized trial on the efficacy of 14 days]
Sponsor: Hospital convalescent plasma compared to best Estimated Study
Universitario Dr. Jose E. available treatment Completion Date: May
Gonzalez 30, 2021
N = 30, hospitalized with Covid-19
requiring supplemental oxygen
Convalescent Plasma NCT04361253 Not stated A phase 3, randomized, double-blinded, Modified WHO Ordinal Scale (MOS) Not yet recruiting Medium
placebo-controlled trial of high-titer score [ Time Frame: Day 14 ]
Sponsor: Brigham and (ESCAPE) COVID-19 Convalescent Plasma (HT- Estimated Study
Women's Hospital CCP) as a possible treatment for people Completion Date:
who have COVID-19 December 2021
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Version of 16.06.2020
Convalescent plasma NCT04348656 Canada Phase 3, Randomized Open-Label Trial Intubation or death in hospital [ Time Not yet recruiting Medium
(multiple sites) of convalenscent plasma for Frame: Day 30 ]
Sponsor: CONCOR-1 hospitalized adults with acute COVID-19 Estimated Primary
Hamilton Health Sciences respiratory illness. Completion Date:
Corporation October 31, 2020
N=1200 subjects ≥16 years old,
admitted to hospital with confirmed
COVID-19 respiratory illness.
Randomized to convalescent plasma or
standard of care.
Convalescent plasma NCT04344535 United States, Phase 1/2, randomized clinical trial Number of days a patient is receiving Enrolling by invitation Medium
New York comparing the Efficacy and Safety of mechanical invasive ventilation through
Sponsor: Stony Brook High-Titer Anti-SARS-CoV-2 Plasma vs. 28 days post randomization. Patients Estimated study
University Standard Plasma in Hospitalized who die during this time period are completion August 31,
Patients With COVID- 19 Infection assigned 0 ventilator free days. 2021
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Version of 16.06.2020
anti-SARS-CoV-2 virus ChiCTR2000030929 Wuhan, China A randomized, double-blind, parallel- Improvement of clinical symptoms Not yet recruiting; Medium
inactivated plasma controlled trial to evaluate the efficacy (Clinical improvement is defined as a Duration:
and safety of anti-SARS-CoV-2 virus reduction of 2 points on the 6-point From 2020-03-17 To
inactivated plasma in the treatment of scale of the patient's admission status 2020-06-16
severe novel coronavirus pneumonia or discharge from the hospital)
(COVID-19).
N=60
Convalescent Plasma NCT04372979 France (multiple Phase 3, randomized, controlled, triple- Survival time without needs of a Not yet recruiting Medium
sites) blinded, parallel clinical trial to tests the ventilator. [ Time Frame: Day 30 ]
Sponsor: 2020-A01166-33 efficacy of convalescent plasma Estimated Study
Direction Centrale du transfusion therapy in the early care of Completion Date: May
Service de Santé des PLASCOSSA COVID-19 hospitalized patients outside 2021
Armées intensive care units.
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Convalescent plasma NCT04385043 Italy A phase 2/3 randomized, open-label Decrease in mortality [ Time Frame: 30 Recruiting Medium
trial to evaluate the efficacy and safety days ]
Sponsor: University of of the hyperimmune plasma Estimated Primary
Catanzaro administered add-on to the anti-Covid- Completion Date:
19 treatment (standard therapy) October 15, 2020
compared to patients treated only with
standard therapy.
N=60
Convalescent Plasma NCT04408040 United States, Phase 2, non-randomized, parallel 1. Arms 1 & 2: lower death rates than Not yet recruiting Low
Georgia assignment, open-label study. the reported fatality rate [ Time Frame:
Sponsor: 30 days after initial treatment ] Estimated Primary
Northside Hospital, Inc. N=700 adult patients with covid-19 Completion Date: June
falling into one of the following groups: 2. Arms 1 & 2: number of patients who 2022
survive the infection [ Time Frame: 30
Arm 1: Critical Patients days after initial treatment ]
Arm 2: Severe Patients
Arm 3: High risk patients 3. Arm 3: number patients with lower
Arm 4: Health care providers incidence of progression to severe or
critical disease than the reported case
All receiving 200-425 mL convalescent rate [ Time Frame: 30 days after initial
plasma donated by patients previously treatment ]
positive for COVID-19
4. Arm 4: number of health care
providers who are at risk to exposure to
COVID-19 who are transfused with
convalescent plasma result in lower
incidence of developing COVID-19
infection than the reported case rate [
Time Frame: 30 days after initial
treatment ]
33
Version of 16.06.2020
Convalescent Plasma NCT04407208 Indonesia Phase 1 single-arm, open-label. Plaque reduction neutralization test Recruiting Low
(PNRT) [ Time Frame: day 7 after first
Sponsor: Biofarma N=10 with confirmed COVID-19 receive transfusion ] Estimated Primary
3 times of each 100 ml convalescent Completion Date:
plasma on day 0, 3, and 6. D-dimer, CRP, INR, Oxygenation Index [ August 1, 2020
Time Frame: day 1,4,7,14 after first
transfusion ]
34
Version of 16.06.2020
Convalescent Plasma ChiCTR2000033056 China, Guizhou Phase 0 interventional study to describe Duration of negative changes Completed Low
the efficacy of convalescent plasma
Sponsor: Guizhou transfusion for COVID-19 patients. From 2020-01-29 To
Provincial Jiangjunshan 2020-04-30
Hospital N = 6 reccurent COVID-19 patients or
COVID-19 patients with Long treatment
cycle to receive, age 51-84 years old.
Convalescent Plasma NCT04392232 United States, Phase 2, open-label, non-randomized, Survival Rate [ Time Frame: At 28 Days ] Recruiting Low
Ohio single arm study to evaluate the
Sponsor: effectiveness of convalescent plasma in Estimated Primary
TriHealth Inc. combatting the symptoms and effects Completion Date:
of COVID-19. December 31, 2020
35
Version of 16.06.2020
Convalescent plasma NCT04389944 Switzerland Open-label, single arm study to 1. Serious adverse events in Recruiting Low
investigate individual treatments using convalescent plasma treated patients [
Sponsor: convalescent severe acute respiratory Time Frame: From baseline (enrolment) Estimated Primary
University Hospital, Basel, Syndrome Coronavirus 2 (SARS-CoV-2) to 24 hours follow-up ] Completion Date: June
Switzerland plasma in SARS-CoV-2 infected patients 30, 2020
at risk for disease progression. 2. Virologic clearance in nasopharyngeal
swab of convalescent plasma treated
N=15 subjects with moderate to severe patients [ Time Frame: at Baseline
disease at risk for transfer to intensive (admission to Covid-ward), day -1
care unit or patients at the intensive (before plasma), day 1 (after plasma),
care unit with limited treatment day7, day 14, day 28 ]
options will be treated.
3. Transfer to ICU [ Time Frame: at
Baseline (admission to Covid-ward) until
day 28 ]
N=100
Inactivated Convalescent NCT04385186 Colombia Phase 2, single-blinded, controlled, Mortality reduction in CoViD-19 Not yet recruiting low
Plasma (multicenter) randomized trial on the ude of patients treated with inactivated
inactivated convalescent plasma as a convalescent plasma + support Estimated Primary
Sponsor: National Blood Therapeutic Alternative in Hospitalized treatment [Time Frame: Over a period Completion Date:
Center Foundation, Patients CoViD-19 of 28 days] September 30, 2020
Hemolife
N = 60, hospitalized with covid-19
associated pneumonia, ARDS, sepsis or
36
Version of 16.06.2020
septic shock randomized to
Convalescent plasma+Support
treatment selected by the hospital or
support treatment alone
Convalescent plasma NCT04385199 United States, A phase 2, randomized, open-label pilot Improvement in respiratory disease [ Recruiting Low
Michigan study of tolerability and efficacy of Time Frame: day 1 post transfusion ]
Sponsor: Henry Ford transfusion of convalescent plasma Estimated Primary
Health System compared to standard of care Completion Date:
August 1, 2020
N = 30 patients with COVID-19
respiratory disease
Convalescent Plasma NCT04384588 Chile A phase 2/3 open-label, 4 arms , non 1.in-hospital mortality secondary to Recruiting Low
randomized clinical trial assessing the COVID-19 among patients treated with
Sponsor: Fundacion Arturo use of convalescent plasma from convalescent plasma [ Time Frame: 1 Estimated Primary
Lopez Perez COVID-19 recovered donors year ] Completion Date:
2.safety of the use of convalescent April 6, 2021
N = 100 oncological and non- plasma drom COVID 19 donors [ Time
oncological patients with current severe Frame: 1 year ]
COVID-19 infection or in patients with
risk factors of major complications
secondary to COVID-19 infection
Convalescent Plasma NCT04384497 Sweeden Phase 1/2, single group assignment, Number and proportion of patients Recruiting Low
open-label, non-randomised controlled with progression to ventilation or
Sponsor: safety and dose identifying trial. sustained requirement of Estimated Primary
Joakim Dillner, Karolinska supplementary oxygen therapy [ Time Completion Date: June
University Hospital N=50 hospitalzed subjects with active Frame: Measured in the first 28 days 2020
COVID-19 defined as symptoms + SARS after inclusion. ]
CoV-2 identified from upper or lower
airway samples.
37
Version of 16.06.2020
Convalescent plasma NCT04383548 Not stated A open-label clinical study for efficacy 1.Efficacy of COVID19 hyper Not yet recruiting Low
of anti-corona VS2 immunoglobulins immunoglobulins for patients [ Time
Sponsor: Assiut University prepared from COVID19 convalescent Frame: 2 weeks ] Estimated Primary
plasma in prevention of infection in 2.Efficacy of COVID19 hyper Completion Date:
high risk groups as well as treatment of immunoglobulins for high risk groups [ December 1, 2020
early cases of COVID19 patients Time Frame: 1 month ]
3.Safety of anti-SARS-CoV-2 hyper
N = 100 immunoglobulins assessed by
percentage of adverse events [ Time
Frame: 72 hours ]
Convalescent plasma NCT04380935 Indonesia A phase 2/3 randomized, open-label All-cause mortality [ Time Frame: up to Not yet recruiting Low
study to evaluate the effectiveness and 28 days ]
Sponsor: Indonesia safety of convalescent plasma therapy Estimated Primary
University compared to standard of care Completion Date:
August 31, 2020
N = 60 COVID-19 patients with acute
respiratory distress syndrome
Convalescent Plasma NCT04377672 USA? Phase 1, single group assignment, open- Safety of treatment with high-titer anti- Not yet recruiting Low
label study to evaluate the safety of SARS-CoV-2 plasma as assessed by
Sponsor: administration of plasma containing adverse events [ Time Frame: 28 days ] Estimated Primary
Johns Hopkins University antibodies to the SARS-CoV-2 virus (i.e., Completion Date: May
convalescent plasma) and if it is able to 18, 2021
prevent disease or lessen the severity of
disease in individuals who are at high
risk of developing COVID-19 due to a
recent exposure.
N=30
Hyperimmune plasma NCT04321421 Italy Interventional, open label Death within 7 days (death from any Recruiting Low
N=49 cause)
San Matteo Age: 18 and above Initiated on Mar 17,
Hospital Longitudinal assessment of COVID-19 2020
pts treated with hyperimmune plasma Estimated Primary
completion:
31.05.2020
Convalescent Plasma NCT04365439 Switzerland ??? Single-group assignment, open-label 1. Titers of anti-SARS-CoV-2 antibodies Not yet recruiting Low
trial to evaluate convalescent plasma in the plasma derived from
Sponsor: for the treatment of moderate-severe convalescent donors [ Time Frame: At Estimated primay
Enos Bernasconi COVID-19. plasma donation ] Completion Date: May
2. Change in titers of anti-SARS-CoV-2 30, 2020
N=10 hospitalized adult patients with antibodies in patients' plasma [ Time
confirmed COVID-19 infection Frame: Change from baseline at day 21
]
3. Change in inflammatory cytokines
concentration (e.g. IL-6, HMGB1) [ Time
Frame: Change from baseline at day 7 ]
38
Version of 16.06.2020
4. Viral load decay in the recipient after
plasma transfusion with
semiquantitative assessment of
nasopharyngeal swabs [ Time Frame:
Change from day of diagnosis at day 1 ]
Convalescent plasma NCT04357106 Mexico A phase 2, open-label, single group, Lung injury [ Time Frame: 7 days] Recruiting Low
clinical trial.
Sponsor: Centro de (COPLA) Overall survival [ Time Frame: 15-30 Estimated Primary
Hematología y Medicina N = 10 days ] Completion Date: July
Interna 2020
Convalescent Plasma NCT04360486 Not stated Expanded access open-label, single- Not Applicable Available Low
arm, multi-site protocol to provide
Sponsor: U.S. Army convalescent plasma as a treatment for
Medical Research and patients diagnosed with severe, or life-
Development Command threatening COVID-19
Convalescent Plasma NCT04358211 United States, Expanded Access to Convalescent Not applicable Available Low
Expanded access Louisiana Plasma to Treat and Prevent Pulmonary
Complications Associated With COVID-
19.
Population:
1)intubated, mechanically ventilated
patients with confirmed COVID-19
pneumonia by chest X-ray or chest CT.
2)hospitalized patients with acute
respiratory symptoms between 3 and 7
days after the onset of symptoms, with
COVID-19.
Convalescent Plasma NCT04356534 Bahrain A prospective and randomized open Requirement for invasive ventilation [ Not yet recruiting Low
label trial to compare plasma therapy Time Frame: 10 day or until discharge ]
Sponsor: Royal College of using convalescent plasma with Estimated primary
Surgeons in Ireland - antibody against SARS-CoV-2 to usual Completion Date: May
Medical University of supportive therapy in COVID-19 3, 2020
Bahrain N = 40 patients with pneumonia and
hypoxia with the criteria that all require
oxygen therapy.
Convalescent plasma NCT04356482 Mexico Phase 1/2, open-label, one-armed study Clinical improvement Not yet recruiting Low
evaluating what is the minimum
Sponsor: Instituto de (COPLASCOV19) effective dose necessary of Improvement in tomographic image Estimated Study
Seguridad y Servicios convalescent plasma for getting better Completion Date:
Sociales de los in severly ill (not intubated) or very Test positivity for COVID-19 December 2020
Trabajadores del Estado severely ill (intubated) patients
Early and late complications associated
N = 90 to convalescent plasma
39
Version of 16.06.2020
CoVID-19 Plasma NCT04355897 Single group assignment. Mortality Recruiting; Low
United States, N=100 patients hospitalised with covid- Estimated Primary
Sponsor: Ohio 19 Completion: July 2020
The Christ Hospital
Convalescent plasma NCT04354831 United States, Phase 2, open label, non-randomized Overall Mortality within 60 days [ Time Not yet recruiting Low
Wisconsin trial assessing the efficacy and safety of Frame: sixty days from infusion of
Sponsor: anti-SARS-CoV-2 convalescent plasma in plasma ] Estimated Primary
Medical College of hospitalized patients with acute severe Completion Date: May
Wisconsin respiratory symptoms from COVID-19. 1, 2022
N=131 divided in a ICU cohort and a
hospitalized non-ICU cohort – both
cohorts receive anti-SARS-CoV-2
convalescent plasma.
Convalescent plasma ChiCTR2000031501 China, Hubei Non randomized, prospective cohort Hospital mortality [Time frame: until Not yet recruiting Low
study to explore whether convalescent hospital discharge or death]
Sponsor: plasma can improve the clinical From 2020-03-17 To
Eastern theater General prognosis of severe and critical covid-19 2020-07-17
Hospital, China, Jiangsu patients.
40
Version of 16.06.2020
one month after transfusion, Up to 12
weeks. ]
Convalescent antibodies NCT04346589 Italy, multiple Open-label, single group assignment, Number of mechanical ventilation days. Not yet recruiting Low
sites pilot study to explore the efficacy and [ Time Frame: Through study
Sponsor: safety of rescue theraphy with completion, an average of 6 months. ] Estimated Primary
A.O. Ospedale Papa antibodies from convalescent patients Completion Date: July
Giovanni XXIII obtained with double-filtration 2020
plasmapheresis (DFPP) and infused in
critically Ill ventilated patients with
COVID-19
N=10
Convalescent Plasma NCT04346446 India A pilot randomized, open-label, Proportion of patients remaining free of Recruiting Low
controlled trial. mechanical ventilation in both groups
Sponsor: Institute of Liver Estimated Study
and Biliary Sciences, India N = 20 severe patients randomized to Completion Date: June
receive either standard medical therapy 30, 2020
(supportive therapy) or up to 500 ml of
convalescent plasma and standard
medical therapy
Convalescent plasma NCT04345991 France Phase 2, Multiple Randomized Survival without needs of ventilator Not yet recruiting Low
Controlled Trials Open-label study to utilization or use of immunomodulatory Estimated Primary
Sponsor: Assistance CORIPLASM evaluate the efficacy of convalescent drugs [ Time Frame: At day 14 after Completion Date: May
Publique - Hôpitaux de plasma to treat SARS-COV2 infected randomization ] 15 , 2020
Paris patients. WHO progression scale ≥6 [ Time
Frame: at day 4 of randomization ]
N=120 patients included in the
CORIMUNO-19 cohort randomized to
experimental group or control group.
Convalescent plasma 2020-001310-38 Germany A randomized, prospective, open label Composite endpoint of: ongoing Low
clinical trial on the use of convalescent - Survival AND
Fresh frozen plasma (FFP) CAPSID2020-DRK-BSD plasma compared to best supportive - no longer fulfilling criteria of severe
with marketing care in patients with severe COVID-19 COVID-19 within 21 days after
authorisation in Germany N=106 patients with severe COVID-19 randomization
issued by Paul-Ehrlich- ransomised to convalescent plasma or
Institute standard of care
Convalescent Plasma NCT04338360 Mayo cilnics in Expanded access Not stated Available Low
Arizona, Florida, Patients in acute care facilities infected
Sponsor: Mayo Clinic Minnesota, with SARS-CoV-2 who have severe or
Wisconsin, life-threatening COVID-19, or who are
United states judged by a healthcare provider to be at
high risk of progression to severe or
life-threatening disease.
41
Version of 16.06.2020
Immunoglobulin from ChiCTR2000030841 China, Hubei, Non randomized control study to Time to Clinical Improvement (TTCI) Recruiting Low
cured COVID-19 patients Wuhan evaluate the efficacy and safety of
immunoglobulin from cured COVID-19 Study execute time:
Sponsor: patients in the treatment of acute 2020-02-17 to 2020-
Union hospital of Tongji severe COVID-19 05-31
Medical College, Huazhong
University of Science and N=10 diagnosed with acute severe
Technology 2019-nCoV pneumonia.
Experimental group (n=5):
Immunoglobulin of cured patients
Control group (n=5): gamma-Globulin
anti-SARS-CoV-2 NCT04345679 Not stated yet Single arm study Changing of viral load of SARS-CoV2 [ Not yet recruiting; Low
convalescent plasma N=20 patients with COVID-19 Time Frame: Day 1,3, 7, 12 ]
Sponsor: Estimated Primary
Orthosera Kft. Completion: June 1,
2020
Convalescent plasma NCT04340050 Early phase 1 study. Single arm study. Feasibility; Recruiting; Low
United States, N=10 patients with severe or critical Type of respiratory support [ Time Estimated Primary
Sponsor: Illinois COVID-19 Frame: 28 days after plasma Completion:
University of Chicago administration ] December 31, 2020
Infusion of blood plasma Very early news France Randomised, half to receive TBD Not recruiting
from COVID-19 survivors https://www.straitstime convalescent plasma
s.com/world/france-to-
test-plasma-of- N=60
coronavirus-survivors-
to-treat-sick
Paris hospital authority
AP-HP, the National
Medical Research
Institute INSERM, and
the National Blood
Service EFS
HB-adMSCs NCT04349631 Texas, US Phase II, open label, single-center, 1) Incidence of hospitalization for Enrolling Low
(Hope Biosciences prevention COVID-19
Autologous Mesenchymal N: 56 Estimated study
Stem Cell Therapy) All ages and all sexes 2) Incidence of symptoms for COVID-19 completion date: Dec
31, 2020
Sponsor: Hope Biosciences [ Time Frame: Week 0 through week 26
(end of study) ]
Convalescent Plasma NCT04332835 Columbia Open label randomised trial. Change in Viral Load [ Time Frame: Days Not yet recruiting; Low
N= 80 patients with moderate COVID- 0, 4, 7, 14 and 28 ] Estimated Primary
19 Completion: August
Randomised to Convalescent Plasma + Change in Immunoglobulin M COVID-19 31, 2020
azithromycin + hydroxychloroquine or Titers [ Time Frame: Days 0, 4, 7, 14 and
azithromycin + hydroxychloroquine 28 ]
42
Version of 16.06.2020
N=15
Convalescent plasma ChiCTR2000029850; Zhejiang, China Prospective cohort study; Fatality rate Recruiting; Low
treatment http://www.chictr.org.c N=20 with severe covid-19 From2020-02-15 To
n/showproj.aspx?proj=4 2022-02-15
9533
Convalescent plasma ChiCTR2000030039 Jiangsu 90 patients with normal to critical Recruiting, Low
treatment http://www.chictr.org.c covid-19. SARS-CoV-2 DNA, Unknown end-date
n/showproj.aspx?proj=4 N=30 treated with convalescent plasma And SARS-CoV-2 antibody levels
9544 N=60 treated with conventional therapy
Convalescent plasma ChiCTR2000030627 He’nan, China Randomised controlled trial. Temperature, Recruiting; Low
http://www.chictr.org.c N=30 patients with severe or critical Virus nucleic acid detection
n/showproj.aspx?proj=5 covid-19 randomised 1:1 to From2020-02-01 To
0727 convalescent plasma or conventional 2020-05-30
treatment
43
Version of 16.06.2020
Hyperimmune Plasma NCT04321421 Pavia, PV, Italy Single arm treatment of 49 patients death [ Time Frame: within 7 days ] Active, not recruiting; Low
with moderate to severe COVID-19 Estimated primary
undergoing mechanical ventilation or completion: May 31,
continuous positive airway pressure. 2020
Convalescent Plasma NCT04325672 United States, An Open Label, Phase 2A Study of High- Change in RNA levels of SARS-CoV-2 Not yet recruiting; Low
Minnesota Titer Anti-SARS-CoV-2 Plasma in from nasopharyngeal across time; Estimated Primary
Hospitalized Patients With COVID-19 ICU Admissions; Completion:
N=20 patients In-hospital mortality; December 31, 2022
Hospital Length of Stay
Convalescent Plasma NCT04327349 Iran Single group assignment; 15 primary outcomes stated, among Enrolling by invitation Low
N=30 those, 10- and 30 days mortality
Convalescent Plasma NCT04343261 United States, Phase 2, single center, open label, 1. Mortality within 28 days. Recruiting. Low
Connecticut single group assignment to investigate 2. Reduction of viral load within 7 Study started on 10
Sponsor: Saint Francis Care treatment with convalescent plasma days. April 2020.
from previously COVID-19 infected Change in Serum Antibody Titers within Recruiting
persons. 7 days.
Estimated Primary
N = 15, aged 18 to 90 years old, with Completion Date:
laboratory confirmed COVID-19 with 01 December 2020.
clinical status as severe or immediately
life-threatening.
Convalescent Plasma NCT04363034 Not stated An expanded access treatment protocol Not applicable Available Low
to treat up to 100 subjects with severe
Sponsor: University of or life-threatening, laboratory
Arkansas confirmed COVID-19 with COVID-19
convalescent plasma
Convalescent Plasma NCT04332380 Columbia Single arm study of N=10 patients Change in Viral Load; Estimated Primary Low
hospitalised with COVID-19 Change in Immunoglobulin M and G Completion: August
COVID-19 antibodies Titers 31, 2020
Anti-SARS-CoV-2 ChiCTR2000030381 Hubei, China Randomized, open-label, controlled and Clinical symptom improvement rate: Not yet recruiting Low
inactivated convalescent http://www.chictr.org.c single-centre trial improvement rate of clinical symptoms
plasma n/showproj.aspx?proj=5 = number of cases with clinical From2020-02-29 To
0290 N=40 patients with moderate covid-19 symptom improvement /number of 2020-05-31
enrolling cases * 100%
Anti-SARS-CoV-2 ChiCTR2000030312 Hubei, China Single arm n=24 treated with anti-SARS- Clinical symptom improvement rate: Cancelled due to Low
inactivated convalescent http://www.chictr.org.c CoV-2 inactivated convalescent plasma improvement rate of clinical symptoms modification of
plasma n/showproj.aspx?proj=5 = number of cases with clinical protocol (new study
0258 symptom improvement /number of number
enrolling cases * 100% (ChiCTR2000030381)
Convalescent Plasma NCT04374565 United States, A phase 2, single-group, open-label 1.Transfer to ICU [ Time Frame: Days 0 - Not yet recruiting Low
Virginia study to to assess preliminary efficacy 60 ]
Sponsor: University of and confirm safety of infusions of high Estimated Study
Virginia titer antiSARS-CoV-2 convalescent 2.28 day mortality [ Time Frame: Days 0 Completion Date:
plasma - 60 ] April 5, 2021
44
Version of 16.06.2020
N = 29 hospitalized patients with acute
respiratory symptoms with or without
confirmed interstitial COVID-19
pneumonia by CXR or chest CT.
Plasma exchange NCT04374539 Spain A phase 2, open label randomized Impact of plasma exchange [ Time Recruiting Low
controlled clinical trial to evaluate the Frame: 28 days ]
Sponsor: Fundacion Clinic efficacy of plasma exchange in critically Estimated Study
per a la Recerca Biomédica ill patients with COVID-19 disease. Completion Date:
August 29, 2021
N = 116 patients admitted in ICU with
invasive mechanical ventilation;
Convalescent Plasma NCT04374526 Italy A phase 2/3, randomized, open-label Rate of COVID-19 progression [ Time Not yet recruiting Low
trial to evaluate whether early Frame: days 1 to 14. ]
Sponsor: Fondazione transfusion of COVID-19 convalescent Proportion of patients without Estimated Study
Policlinico Universitario plasma in elderly COVID-19 patients can progression in severity of pulmonary Completion Date: June
Agostino Gemelli IRCCS prevent disease progression. disease defined as worsening of 2 30, 2021
points in the ordinal scale of WHO
N = 182 patients age ≥ 65 within day 14
Convalescent plasma NCT04374487 India Phase 2, open-label, controlled, The primary outcome is a composite Not yet recruiting Medium
randomized trial on the Efficacy of measure of the avoidance of - 1.
Sponsor: Max Healthcare Convalescent Plasma to Limit COVID-19 Progression to severe ARDS (P/F ratio Estimated Study
Insititute Limited Associated Complications 100) Completion Date: May
9, 2021
N = 100, age 18-85, with confirmed All-cause Mortality at 28 days [Time
Covid-19 and any of the two: Frame: depends on the total treatment
1. PaO2/ FiO2 <300 time of the subjects within one year
2. Respiratory Rate > 24/min and SaO2 period of the trial.]
< 93% on room air randomized to
receive convalescent plasma or
standard of care
Convalescent Plasma NCT04374370 United States, Expanded Access Protocol on use of Not stated Available
Florida Convalescent Plasma for Covid-19
Sponsor: AdventHealth
N: Intermediate-size Population, age 6-
99 with severe or immediately life-
threatening Covid-19 infection
Convalescent Plasma NCT04372368 United States, Expanded access program to provide Not Applicable Available Low
Colorado COVID-19 convalescent plasma to
Sponsor: University of patients with moderate to severe or
Colorado, Denver life-threatening manifestations of
COVID-19, or documented to be at high
risk of developing such manifestations.
45
Version of 16.06.2020
Convalescent plasma NCT04375098 Chile A phase 2 open-label randomized trial Percentage Mechanical Ventilation, Recruiting Low
in which patients with high risk of hospitalization longer than 14 days or
Sponsor: Pontificia COVID19-associated respiratory failure death during hospitalization [ Time Estimated Primary
Universidad Catolica de will be randomized to early treatment Frame: 1 year follow up ] Completion Date:
Chile with convalescent plasma. December 2020
N = 30
Immunoglobulins
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Human immunoglobulin NCT04350580 France Randomised, double-blinded, placebo- Ventilator-free days [ Time Frame: 28 Recruiting; High
controlled trial. days ] Estimated Primary
Sponsor: Sponsor: ICAR N=138 patients with SARS-CoV-2 and Completion; June
Centre Hospitalier St Anne ARDS randomized to immunoglobulin 2020
or placebo
Octagam 10% 2020-002482-34 United States Phase 3, randomized, placebo- Stabilization or improvement in clinical Estimated Primary High
controlled, double-blinded trial to status defined as maintenance or Completion Date:
Sponsor: GAM10-10 (multiple sites evaluate the efficacy and safety of improvement by one category on a 6- 2020-08-21
Octapharma USA globally) Octagam 10% therapy in COVID-19 category clinical status scale on Day 7.
NCT04400058 patients with severe disease 1. Hospital discharge or meet discharge
progression criteria (discharge criteria are defined
as clinical recovery, i.e. fever,
N=54 adults with RT-PCR confirmed respiratory rate, oxygen saturation
COVID-19 infection randomized to return to normal, and cough relief).
Octagam 10% infusion or placebo. 2. Hospitalization, not requiring
supplemental oxygen.
3. Hospitalization, requiring
supplemental oxygen (but not
NIV/HFNC).
4. ICU/hospitalization, requiring
NIV/HFNC therapy.
5. ICU, requiring Extracorporeal
Membrane Oxygenation (ECMO) and/or
IMV.
6. Death.
Intravenous NCT04411667 United States, Phase 4, multicentre, randomized, Mechanical Ventilation [ Time Frame: Recruiting Low
Immunoglobulin (IVIG) California open-label study to identify whether or from date of patient admission to date
/Octagam not IVIG can halt the progression to of patient discharge or date of death, Estimated Primary
respiratory failure requiring mechanical whichever came first, assessed up to 45 Completion Date:
Sponsor: ventilation in subjects admitted to the days ] November 1, 2020
George Sakoulas, MD, hospital with confirmed COVID-19
Sharp HealthCare
46
Version of 16.06.2020
N=40 randomized 1:1 to standard of
care + Octagam infusion for 3 days or
standard of care alone.
Monoclonal antibodies
Tocilizumab (RoActemra) alone or in combination with other drugs
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors and has been shown to inhibit soluble and membrane-bound IL-
6R-mediated signaling. Licensed.
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Tocilizumab ChiCTR2000029765 Anhui, China Phase 4, Randomised controlled trial. Cure rate Recruiting High
http://www.chictr.org.c Blinding not stated
Sponsor: n/showprojen.aspx?proj May 10, 2020
The First Affiliated Hospital =49409 N=198
of University of science Severe cases of covid19 randomised to
and technology of China tocilizumab, or
(Anhui Provincial Hospital) conventional treatment
Tocilizumab NCT04320615 Canada Randomized, Double-Blind, Placebo- Clinical Status Assessed Using a 7- Recruiting; High
Denmark Controlled, Multicenter Study Category Ordinal Scale [ Time Frame:
Sponsor: Roche EudraCT: 2020-001154- France Day 28 ] Estimated primary
22 Germany N=330 Patients With Severe COVID-19 completion: August
Ireland randomised to Tocilizumab or placebo 31, 2021
Italy
Netherlands
Spain
Sweden
Switzerland
United Kingdom
United States
Tocilizumab vs NCT04322773 Denmark An Open-Label, Multicenter Sequential Time to independence from Recruiting; Estimated High
sarilumab and Cluster Randomized Trial; supplementary oxygen therapy Primary Completion:
EudraCT: 2020-001275- N=200 patients with severe COVID-19 June 1, 2021
32 randomised to
RoActemra iv,
RoActemra sc,
Kevzara sc, or
Standard medical care
Tocilizumab NCT04335071 Switzerland A multicenter, double-blind, Number of patients with ICU admission Recruiting; Estimated High
randomized controlled phase II trial [ Time Frame: 7 days after Primary Completion:
Sponsor: randomisation ] October 2020
University Hospital N=100 hospitalised with COVID-19
Inselspital, Berne randomised to
47
Version of 16.06.2020
tocilizumab or Number of patients with intubation [
Placebo Time Frame: 14 days after
randomisation ]
Number of patients with death [ Time
Frame: 28 days after randomisation ]
Tocilizumab NCT04356937 United States, Phase 3, double-blinded, placebo- Proportion of patients that require Not yet recruiting High
Massachussets controlled, randomized trial on mechanical ventilation [Time Frame: 28
Sponsor: Massachusetts Tocilizumab to Prevent the Progression days] Estimated primary
General Hospital of Hypoxemic Respiratory Failure Completion Date: June
30, 2020
N = 300, age > 18, Hospitalized Non-
Critically Ill Patients With COVID-19,
randomized 2:1 to Tocilizimab or
placebo
Tocilizumab NCT04372186 Not stated Phase 3, randomized, double-blind, Cumulative Proportion of Participants Not yet recruiting High
placebo-controlled, multicenter study Requiring Mechanical Ventilation by
Sponsor: to evaluate the efficacy and safety of Day 28 [ Time Frame: Up to Day 28 ] Estimated Primary
Genentech, Inc Tocilizumab in hospitalized patients Completion Date:
with COVID-19 Pneumonia. August 5, 2020
48
Version of 16.06.2020
Tocilizumab NCT04331808 Not stated Randomized Controlled Trials Open- Survival without needs of ventilator Not yet recruiting; Medium
label. utilization at day 14; Estimated Primary
Sponsor: Assistance N=240 patients included in the WHO progression scale <=5 at day 4; Completion: March
Publique - Hôpitaux de CORIMUNO-19 cohort Cumulative incidence of successful 31, 2021
Paris tracheal extubation;
WHO progression scale <=7 at day 4
Tociliuzumab NCT04363736 Not applicable Phase 2, Open-Label, Randomized, Concentration of C-Reactive Protein Not yet recruiting Medium
Multicenter Study to Investigate the (CRP) [Time Frame: Day 7] Estimated primary
Sponsor: Hoffmann-La Pharmacodynamics, Pharmacokinetics, Completion Date: June
Roche Safety, and Efficacy of Intravenous 11, 2020
Tocilizumab in Patients With Moderate
to Severe COVID-19 Pneumonia.
49
Version of 16.06.2020
Tozilizumab + NCT04335305 Not stated A Multicenter, Randomized, Open- Percentage of patients with Not yet recruiting; Medium
Pembrolizumab Label, Phase II Trial normalization of SpO2 ≥96% Estimated Primary
N=24 patients with severe COVID-19 Completion: May 15,
randomised to Tozilizumab + 2020
Pembrolizumab or standard of care
Ciclosporin, Tocilizumab 2020-001437-12 Spain Phase 4, randomized, controlled, open- Mortality at day 28 after treatment Ongoing Medium
label, parallel group, 4-armed, one-site initiation (proportion of patient died Start date: 2020-04-09
Sponsor: trial in adult patients with COVID-19 that day). Estimate of duration:
Fundació Hospital severe pneumonia treated with 6 months
Universitari Vall d'Hebron - immunomodulatory drugs + standard
Institut de Recerca (VHIR) care
N=290
Tocilizumab vs sarilumab EudraCT: 2020-001246- France Randomised, open label trial. For patients not requiring ICU: Recruiting; Medium
18 Moderate, severe or critical COVID-19 Co Primary Endpoints March 27, 2021
Sponsor: Assistance NCT04324047 N=1000 randomised to sarilumab, 1. Survival without needs of ventilator
Publique - Hôpitaux de tocilizumab, utilization at day 14.
Paris CORIMUNO-19 trial or standard of care. 2. Early end point: OMS progression
scale < or = 5 at day 4
For patients requiring ICU:
Co Primary Endpoints
1. Cumulative incidence of successful
tracheal extubation at day 14.
2. Early end point: OMS progression
scale >7 at day 4
Tocilizumab NCT04330638 Belgium Open label, Prospective, Randomized, Time to Clinical Improvement Recruiting; Medium
Siltuximab Factorial Design, Interventional Study Estimated Primary
Anakinra EudraCT: 2020-001500- N=342 randomised to Completion:
41 Anakinra September 2020
Siltuximab,
Siltuximab + Anakinra,
Tocilizumab,
Tocilizumab + Anakinra, or
Standard of care
Tocilizumab 2020-001995-13 Spain Phase 2, multicentre, single arm, open- Respiratory function, defined as: Ongoing Low
label clinical trial to evaluate the - Start date of intubation (in patients
Sponsor: BREATH-19 effectiveness and safety of intravenous not previously initiated). Estimated Primary
Fundación SEIMC-GESIDA tocilizumab for treating patients with - Date of extubation. Completion Date:
COVID-19 pneumonia - Start date of NIMV and date of 2020-08-21
independence from NIMV (duration of
N=500 adult hospitalized subjects NIMV).
diagnosed with COVID-19 pneumonia - Start date of oxygen therapy and date
by RT-PCR of independence from oxygen therapy
(duration of oxygen therapy).
Mortality rate.
50
Version of 16.06.2020
51
Version of 16.06.2020
5.Blood chemistry [Time Frame: 48/72
hours and 7/14 days]
Tocilizumab and NCT04361032 Tunisia Phase 3, randomized, open-label clinical The mortality rate [ Time Frame: 90 day Not yet recruiting Low
Deferoxamine trial to evaluate the efficacy and safety ]
(TRONCHER) of tocilizumab compared to Estimated Primary
Sponsor: Abderrahmane deferoxamine Completion Date: Sept
Mami Hospital 4, 2020
N = 260 COVID-19 (+) patients,
hospitalized in intensive care
Tocilizumab NCT04359667 Croatia A prospective, observational, single 1.Serum interleukin-6 and soluble Recruiting; Low
center study to assess the role of interleukin-6 receptor as biomarkers of Estimated Study
Sponsor: University (UHID-COVID19) interleukin-6 and soluble interleukin 6 clinical outcomes in patients with Completion Date:
Hospital for Infectious receptor as predictors of efficacy and severe coronavirus disease (COVID-19) April 15, 2021
Diseases, Croatia safety outcomes in patients with severe pneumonia treated with tocilizumab at
coronavirus disease pneumonia treated baseline, 24 hours post treatment, 48
with tocilizumab hours post treatment, day and day 28.
N = 398
Tocilizumab NCT04331795 United States, Single arm study Clinical response and biological Recruiting; Low
Illinois N=50 hospitalised patients with COVID- response Estimated Primary
19 Completion: July 1,
2020
Tocilizumab + ivig (human ChiCTR2000030442 Shaanxi, China Single arm study of 100 patients with In hospital time Not yet recruiting Low
antibodies?) + CRRT http://www.chictr.org.c severe covid-19 From2020-03-05 To
(continuous renal n/showproj.aspx?proj=5 2020-05-15
replacement therapy?) 0380
Tocilizumab; NCT04306705 Tongji hospital, A Retrospective Study Proportion of Participants With Recruiting; Low
Sponsor: Tongji hospital Hubei, China N=120 with cytokine release syndrome Normalization of Fever and Oxygen
with Serum IL-6 ≥3 times the upper Saturation Through Day 14 Estimated primary
limit of normal completion: May 30
treated with 2020.
Tocilizumab or Continuous Renal
Replacement Therapy
52
Version of 16.06.2020
Tocilizumab NCT04315480 Ancona, AN, Single arm study Rate of patients with no need in Active, not recruiting; Low
Sponsor: Università Italy N=30 with severe covid-19 increase of FiO2 to maintain stable SO2 Estimated primary
Politecnica delle Marche and no need of intubation; Completion
improving in pulmonary function [ Time 09.04.2020
Frame: 7 days]
Tocilizumab + 2020-001160-28 Spain Phase 2, randomized, controlled, open- Percentage of patients with Ongoing Low
Pembrolizumab label trial to evaluate the efficacy and normalization of SpO2 ≥96% through
COPERNICO Study safety of Tocilizumab + Pembrolizumab day 14 after study treatment initiation Start date: 2020-04-09
Sponsor:
Medica Scientia Innovation N=24 patients with COVID-19- Estimate of duration:
Research S.L. (MEDSIR) pneumonia who are nonresponsive to 90 days
frontline therapy within 48 hours from
treatment initiation
Tocilizumab vs NCT04345445 Hospital Sungai Open-label, Randomized, Interventional The proportion of patients requiring Not yet recruiting; Low
Methylprednisolon Buloh, Hospital Study to Evaluate the Efficacy and mechanical ventilation [ Time Frame: Estimated Primary
Kuala Lumpur Safety of Tocilizumab Versus Through study completion, and average Completion: October
and Hospital Corticosteroids in Hospitalised COVID- of 6 months ] 31, 2020
Tuanku Jaafar, 19 Patients With High Risk of Mean days of ventilation [ Time Frame:
Malaysia Progression. Through study completion, and average
N=310 ranomised to tocilizumab or of 6 months ]
methylprednisolon
Tocilizumab NCT04332913 Italy This is a prospective observational Percentage of patients with complete Not yet recruiting; Low
clinical study recovery defined as fever Estimated Primary
disappearance and return to normal Completion;
N=30 SpO2 after 14 days from the end of December 31, 2020
treatment with tocilizumab.
Chloroquine Analog NCT04333914 Lyon, Rhône, A Prospective, Controlled, Randomized, 28-day survival rate Not yet recruiting; Medium
(GNS561), an Anti PD-1 France open label, Multicenter Study to Estimated study
(Nivolumab) and an Anti- Compare the Efficacy of a Chloroquine completion June 2020
interleukine-6 Receptor Analog (GNS561), an Anti PD-1
(Tocilizumab) (Nivolumab) and an Anti-interleukine-6
Receptor (Tocilizumab) Versus Standard
of Care in Patients With Advanced or
Metastatic Cancer and SARS-CoV-2
(COVID-19) Infection
N=273 devided into two cohorts:
COHORT 1 (mild symptoms or
asymptomatic): GNS561 vs anti-PD1 vs
standard of care (randomization ratio
1:1:1).
COHORT 2 (moderate/severe
symptoms): GNS561 vs anti-IL6 vs
standard of care (randomization ratio
1:1:1).
53
Version of 16.06.2020
Nivolumab NCT04356508 Hong Kong? A phase 2, open-label, non-randomized, Viral clearance kinetics [ Time Frame: Not yet recruiting Low
single-centre pilot study of nivolumab From diagnosis to recovery, assessed up
Sponsor: Dr Gerry Gin Wai to evaluate efficacy of anti-PD1 to 6 months ] Estimated Primary
Kwok antibody in relation to viral clearance Completion Date: June
and its safety. 20 2020
Sarilumab (Kevzara)
Binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signaling. Licensed for rheumatoid arthritis.
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Sarilumab NCT04315298 USA RCT, double-blind, placebo-controlled, Ph2: fever, O2 need Recruiting – March High
Multicentre on top of supportive care. Ph3: long-term outcomes (e.g. death, 2020
Sponsor: Regeneron + Ph2 hospitalisation, ventilation, O2 supply Estimated completion
Sanofi Ph3 (adaptive, depends on Ph2 results) etc) 09 March 2021
N=400
Adults hospitalized with serious Update: phase 2 has
complications from COVID-19 been stopped and
phase 3 continues
Sarilumab EudraCT nr.: 2020- Canada An adaptive phase 2/3, randomized, Ph2: resolution of fever or discharge Ongoing High
001162-12 France double-blind, placebo-controlled study Ph3: adaptive design. PEP depends on
Sponsor: Sanofi Sarilumab COVID-19 Germany assessing efficacy and safety of Ph2 results.
Protocol number: Israel sarilumab for hospitalized patients with
EFC16844 Italy COVID-19 (Sarilumab COVID-19).
Japan Phase 2 n= 100
Russian Phase 3 n= 200
Federation
Spain
54
Version of 16.06.2020
Sarilumab NCT04327388 France An Adaptive Phase 2/3, Randomized, Time to resolution of fever for at least Recruiting; High
Double-blind, Placebo Controlled Study 48 hours without antipyretics or until Estimated Primary
Same as EudraCT nr.: Assessing Efficacy and Safety of discharge, Completion: July 1,
2020-001162-12? Sarilumab for Hospitalized Patients 2020
With COVID19 Phase 3: The percentage of patients
N=300, reporting each severity rating on the 7-
point ordinal scale [ Time Frame:
Baseline to Day 15
Sarilumab EudraCT number: 2020- Italy Randomized Controlled Trial, multi- Endpoint primario: Clinical Trial High
IL-6 inhibitor 001390-76 center L’endpoint primario dello studio e il Application approved
Licensed for rheumatoid Lead center tempo al miglioramento clinico, definito by Italian competent
arthritis Phase III INMI "L. come il authority AIFA 28 April
Spallanzani" - tempo intercorso tra la prima dose del 2020
Roma farmaco al miglioramento di due punti
(rispetto al
baseline) in una scala ordinale a 7 punti.
La scala ordinale a 7 punti consiste delle
seguenti categorie:
1. non ospedalizzato con la ripresa delle
normali attivita;
2. non ospedalizzato ma incapace di
riprendere le normali attivita;
3. ospedalizzato, senza richiedere
supplemento di ossigeno;
4. ospedalizzato, con necessita di
supplemento di ossigeno;
5. ospedalizzato, con necessita di
ventilazione meccanica non invasiva
(cPAP o NIV);
6. ospedalizzato, con necessita di
ossigenazione extracorporea a
membrana (ECMO) o
ventilazione meccanica invasiva o
entrambe;
7. morte.
Sarilumab 2020-002037-15 Spain Phase 2, multicenter, randomized, The primary endpoint is the proportion Ongoing Medium
open-label study to evaluate the of patients progressing to severe
Sponsor: efficacy and safety of Standard of care + respiratory failure (Brescia-COVID Scale Estimated Primary
Cristina Avendaño Sola Sarilumab vs. Standard of care for the ≥2), ICU admission, or death. [Time Completion Date:
early treatment of COVID-19- frame: From baseline up to Day-15] 2021-04-26
pneumonia in hospitalized patients.
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Version of 16.06.2020
Sarilumab (Kevzara) 2020-001290-74 Spain Phase 3, open-label, controlled, Time to clinical improvement, defined Ongoing Medium
randomized trial on the efficacy of as the time from randomization to a
Sponsor: Consorci Parc de Sarilumab in the early treatment of two-point improvement (from Start date: 2020-04-11
Salut Mar (PSMAR) hospitalized patients with mild to randomization status) on an ordinal
moderate COVID-19 pneumonia scale of seven categories or hospital Estimate of duration:
discharge, whichever occurs first 4 months
N=216, randomized to
Sarilumab added to standard treatment [Time frame: 28 days]
or standard treatment alone
Sarilumab (Kevzara) NCT04357860 Spain Phase 2, open-label, randomized trial Ventilation requirements [Time Frame: Not yet recruiting Medium
on the use of Sarilumab in Adults At day 28 or when the subject is
Maimónides Biomedical Hospitalized With COVID-19 Presenting discharged (whichever occurs first)] Estimated Study
Research Institute of Cytokine Release Syndrome Completion Date: July
Córdoba 27, 2020
N = 120, age ≥ 18 and < 75
Arm 1: Sarilumab 200 mg for 14 days
Arm 2: Sarilumab 400 mg for 14 days
Arm 3: best available treatment for 14
days
Sarilumab NCT04324073 France Bayesian open labelled randomized Survival without needs of ventilator Recruiting; Medium
vs standard of care CORIMUNO-19 - SARI clinical trial utilization at day 14; Estimated Primary
N=240 patients with moderate or WHO progression scale <=5 at day 4; Completion: March
Sponsor: Assistance severe COVID-19 randomised to Cumulative incidence of successful 27, 2021
Publique - Hôpitaux de sarilumab or standard of care tracheal extubation;
Paris WHO progression scale <=7 at day 4
Sarilumab NCT04386239 Not stated Early Phase 1, single assignment, pilot Proportion of patients who show an Not yet recruiting Low
study on the use of Sarilumab in improvement of the respiratory
Sponsor: COVID-SARI-001 patients with COVID-19 infection. function [ Time Frame: 6 weeks ] Estimated Primary
ASST Fatebenefratelli Completion Date:
Sacco N=40 subjects age ≥ 18 years and < 85 December 2020
years, documented severe interstitial
pneumonia with respiratory failure with
positive Covid-19 test.
Sarilumab EudraCT number: 2020- Italy This is an open-label, single arm, dose- Proportion of patients Clinical Trial Low
IL-6 inhibitor 001745-40 escalation design, single center study who show an improvement of the Application approved
Licensed for rheumatoid Lead center respiratory function, described as ≥30% by Italian competent
arthritis Pilot study on the use of INMI "L. decrease in oxygen authority AIFA 26
sarilumab in patiens Spallanzani" – requirement compared to baseline (as March 2020
with covid-19 infection Roma defined as the ratio of O2 flow through
the Venturi mask).
Sarilumab NCT04357808 Spain Phase 2, randomised, open-label, Mean change in clinical status Recruiting Low
single-center, comparative trial of assessment using the 7-point ordinal
Sponsor: Maria del Rosario (SARCOVID) sarilumab plus standard of care vs. scale at day 7 after randomisation [ Estimated Study
Garcia de Vicuña Pinedo standard of care in a 2:1 ratio Time Frame: 7 days from enrolment ] Completion Date: June
2020
56
Version of 16.06.2020
N = 30 hospitalised patients with
moderate to early severe COVID-19
infection
Sarilumab NCT04359901 United States, Phase 2, open-label, randomized, two- Intubation or death [ Time Frame: Recruiting Low
Massachusetts arm trial comparing standard care alone within 14 Days of enrollment ]
to standard care with addition of Estimated Study
sarilumab (anti-IL6R). Completion Date:
April 10, 2023
N = 120 patients with COVID-19
infection of moderate severity.
Sarilumab 2020-001531-27S Spain Randomized, open label trial in adults Proportion of patients requiring or time Ongoing by Low
Fundación para la hospitalized with COVID-19 presenting (in days) until required: 28.04.2020.
Investigación Biomédica cytokine release syndrome. 3-arm study - High flow nasal oxygenation (HFNO) Estimated study
de Córdoba N=120 patients randomized to - Non-invasive mechanical ventilation duration: 6 months
sarilumab sarilumanb 200 mg, 400 mg type BiPAP
or Best available therapy - Non-invasive mechanical ventilation
type CPAP
- Invasive mechanical ventilation
Sarilumab 2020-001634-36 Spain Phase 2, randomized, open, 2-armed, - Time to become afebrile for a Ongoing Low
SARCOVID single-site pilot study. minimum period of 48 hours, without
Sponsor: antipyretics Start date: 2020-04-09
Rosario García de Vicuña N= 30 patients with moderate-severe - Average change in the ordinal scale of
COVID-19 infection 7 points from the inclusion in the study Estimate of duration:
until day 7 (after randomization): 2 months
Time Frame: 1 month
Siltuximab (Sylvant)
Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of
thehexameric signaling complex with gp130 on the cell surface.
Siltuximab is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are HIV negative and human herpesvirus-
8 (HHV-8) negative.
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Siltuximab vs NCT04329650 Barcelona, Phase 2, Randomized, Open-label Study Proportion of patients requiring ICU Not yet recruiting; Medium
Methylprednisolone Spain to Compare Efficacy and Safety of admission at any time within the study Estimated Primary
EudraCT number: Siltuximab vs. Corticosteroids in period. [ Time Frame: 29 days ] Completion: May 20,
Sponsor: Fundació Clínic 2020-001413-20 Hospitalized Patients With COVID19 2020
per a la Recerca Biomèdica Pneumonia
N=100
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Siltuximab (Sylvant) NCT04322188 Italy, Bergamo Retrospective case-control study Reduction in the need of invasive Recruiting; Low
(compassionate use vs matched ventilation, time spent in ICU or 30-day Estimated Primary
Sponsor: EUSA Pharma controls) mortality Completion: May 19,
N=50 2020
Bevacizumab (Avastin)
Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding
of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. Lisenced.
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Bevacizumab; NCT04305106 Double blinded multicentre randomised Proportion of patients whose Not yet recruiting: Medium
Sponsor: Qilu Hospital of China, controlled trial oxygenation index increased by Estimated study
Shandong University Shandong N=118 Severe or Critical Patients With 100mmhg on the 7th day after completion: May 31,
COVID-19 admission [ Time Frame: On the 7th day 2020
Randomised to bevacixumab. after admission ]
No comparator
Bevacizumab NCT04344782 Not stated – Phase 2, randomized, open-label, Proportion of surviving patients without Not yet recruiting Medium
France?? controlled trial. need for intubation for respiratory (estimated study start
Sponsor: CORIMMUNO-BEVA support [ Time Frame: day 14 ] April 15, 2020)
Assistance Publique - N=130 hospitalized COVID-19 patients
Hôpitaux de Paris randomized to Bevacizumab Injection Estimated Primary
or standard of care. Completion Date:
September 30, 2020
Bevacizumab; NCT04275414 China, Phase 2/3 single group assignment Partial arterial oxygen pressure at 24 Recruiting; Low
Approved for certain Shandong hours, 72 hours and 7 days
cancers; N=20 severe and critical COVID-19 Estimated primary
Sponsor: Qilu Hospital of patients completion:
Shandong University April 2020
Bevacizumab 2020-001541-39 Spain Phase 2 open-label pilot study of To evaluate the crude mortality rate at Ongoing Low
bevacizumab as a treatment for 28 days
Sponsor: Fundación para la respiratory distress in patients with Estimated duration of
Investigación Biomédica COVID-19. the trial: 6 months
de Córdoba
N = 22 patients age > 18 to 25 mg/ml
single-dose bevacizumab.
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Version of 16.06.2020
haemophagocytic Sobi.IMMUNO-101 Active: Emapalumab (n=18) Defined as the proportion of patients
lymphohistiocytosis (HLH). Active: Anakinra (n=18) not requiring invasive mechanical
Comparator: SOC (n=18) ventilation or Extracorporeal
Kineret (anakinra) – IL-1 Adult COVID-19 with respiratory membrane oxygenation (ECMO)
receptor antagonist distress
FDA + EMA approved for
CAPS, Still’s disease, FMF,
RA
Gimsilumab is a fully NCT04351243 USA, New York Randomized, double-blind, placebo Primary endpoint: Incidence of Recruiting. High
human monoclonal + Philadelphia controlled mortality by Day 43 Estimated primary
antibody targeting GM- High dose of gimsilumab on Day 1 and a Secondary endpoints: ventilator completion July 2020
CSF. low dose of gimsilumab on Day 8, or requirements, need for ICU level of
Granulocyte macrophage- matching placebo (saline solution) care, duration of hospitalization
colony stimulating factor Estimated enrolment: 270
(GM-CSF), a myelopoietic Study population: Subjects With Lung
growth factor and pro- Injury or Acute Respiratory Distress
inflammatory cytokine, is Syndrome Secondary to COVID19
believed to be a key driver
of lung hyper-
inflammation and to
operate upstream of other
pro-inflammatory
cytokines and chemokines.
Sponsor: Kinevant Sciences
GmbH
Not licensed.
IFX-1, monoclonal EudraCT Number: 2020- NL A pragmatic adaptive open label, Change in PaO2/FiO2 [ Time Frame: Recruiting High
antibody which specifically 001335-28 randomized Phase II/III multicenter Baseline to Day 5 Estimated Primary
binds to the soluble ClinicalTrials.gov study of IFX-1 in Patients with severe Completion: October
human complement split Identifier: NCT04333420 COVID-19 Pneumonia - "PANAMO" 31, 2020
product C5a. N=130
Sponsor: InflaRx GmbH BSC + IFX-1 vs BSC
Not approved.
Leronlimab, PRO140. NCT04347239 US A Phase 2b/3, Randomized, Double Mortality rate at day 14. Recruiting; Estimated High
CCR5 antagonist https://www.clinicaltrial Blind, Placebo Controlled, Adaptive Primary Completion:
Not yet licensed, but sarena.com/news/cytod Design Study. December 31, 2020
several completed or yn-leronlimab-covid-19- N= 390 severely or critically ill patients. Interim analysis will be
ongoing CT in patients second-trial/ performed on the
with HIV or triple-negative https://www.onclive.co Randomised to leronlimab or placebo data from the first 50
breast cancer. m/web- for two weekes. The trial is following patients following two
exclusives/leronlimab- the former phase 2 study in critically ill weeks of leronlimab
covid19-trial-treats-first- patients. This study was conducted in therapy
patients NY. Phase 2 study
included 10 and 8 of
https://www.cytodyn.co them demonstrated
m/newsroom/press- significant
59
Version of 16.06.2020
releases/detail/405/trea improvement after
tment-with-cytodyns- three days in several
leronlimab-indicates- important
significant immunologic bio-
markers (cytokines, IL-
https://apnews.com/Glo 6, and a trend toward
be%20Newswire/9a363c normalization of the
78ce9b4a830052287089 CD4/CD8 ratio)
1c012e
Leronlimab (PRO 140) NCT04343651 United States Phase 2, two-arm, randomized, double Clinical Improvement as assessed by Recruiting. High
blind, placebo controlled multicenter change in total symptom score (for
Sponsor: CytoDyn, Inc. study to evaluate safety and efficacy of fever, myalgia, dyspnea and cough) [ Estimated Primary
leronlimab (PRO 140) in patients with Time Frame: Day 14 ] Completion Date:
mild-to-moderate symptoms of 04 December 2020.
respiratory illness caused by
coronavirus 2019 infection.
N = 75, subjects aged 18 to 99 years
with mild-to-moderate symptoms of
respiratory illness caused by
coronavirus 2019 infection.
LY3127804 NCT04342897 United States, Phase 2, double-blinded, placebo- Number of Ventilator Free Days [ Time Recruiting High
Europe controlled, randomized clinical trial of Frame: Day 1 to Day 28 ]
A selective monoclonal treatment with LY3127804 Estimated Primary
antibody against Completion Date: June
Angiopoietin 2 (Ang2) N=200, patients hopistalized with 12, 2020
pneumonia and presumed or confirmed
Sponsor: Eli Lilly and COVID-19
Company
Randomized to IV LY3127804 or IV
placebo
Lenzilumab; NCT04351152 US, multicentre A Phase 3 Randomized, double-blind Incidence of invasive mechanical Recruiting; High
Not licensed. Placebo-Controlled Study. ventilation (IMV) and/or Mortality [ Estimated Primary
N=238 hospitalised patients with Time Frame: Up to 28 days ] Completion;
A humanized monoclonal COVID-19 randomised to lenzilumab or September 2020
antibody (class IgG1 placebo.
kappa) that targets colony
stimulating factor / An interim analysis is planned for DSMB
granulocyte-macrophage to assess safety & efficacy data
colony stimulating factor.
Originally designed for the
treatment of chronic
myelomonocytic leukemia
(CMML) and juvenile
myelomonocytic leukemia
(JMML).
Sponsor:
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Version of 16.06.2020
Humanigen, Inc.
Levilimab NCT04397562 Russian A phase 3 multicenter, randomized, Mortality rate [ Time Frame: Day 30 ] Recruiting High
Federation double-blind, placebo-controlled clinical
Sponsor: Biocad trial of the efficacy and safety of Estimated Primary
Levilimab (BCD-089). Completion Date:
April 2021
N = 204 patients with severe COVID-19
Canakinumab NCT04362813 France A phase 3, multicenter, randomized, Number of patients with clinical Not yet recruiting High
Germany double-blind, placebo-controlled study response [ Time Frame: Day 3 to Day 29
Sponsor: Novartis 2020-001370-30 Italy to assess the efficacy and safety of ] Estimated primary
Pharmaceuticals Spain canakinumab plus standard-of-care Completion: October
(CAN-COVID) United Kingdom (SOC) compared with placebo plus SOC 5, 2020
United States
N = 450 adult patients with COVID-19-
induced pneumonia and cytokine
release syndrome (CRS).
Sirukumab NCT04380961 United States Phase 2, randomized, double-blind, Time to Improvement of at Least 2 Recruiting High
(multiple sites) placebo-controlled study to evaluate Categories Relative to Baseline on the
Sponsor: the clinical response of sirukumab plus 6-Point Ordinal Clinical Recovery Scale [ Estimated Primary
Janssen Pharmaceutica standard of care in COVID-19. Time Frame: Up to Day 28 ] Completion Date: June
N.V., Belgium 25, 2020
N=270 hospitalized subjects with
laboratory-confirmed SARS-CoV-2
randomized to Sirukumab (5 mg/kg IV
single dose infusion) + standard of care
or placebo + standard of care.
Adalimumab ChiCTR2000030089 Shanghai, China A randomized, open-label, controlled TTCI (Time to Clinical Improvement) Not yet recruiting; Low
http://www.chictr.org.c trial
n/showproj.aspx?proj=4 N= patients with severe or critical covid- From2020-02-28 To
9889 19 2020-08-31
Avdoralimab (Anti-C5aR NCT04371367 France A phase 2, randomized, double-blinded, 1.Number of patients alive and no Recruiting Medium
Antibody) placebo-controlled clinical trial to longer hospitalized at D14
evaluate Avdoralimab . 2.Number of ventilator-free days at Day Estimated Study
Not licensed 28 (VFD28) Completion Date:
Sponsor: Assistance N = 108 COVID-19 patients with severe October 27, 2020
Publique Hopitaux De pneumonia
Marseille
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SNDX-6352 (axatilimab) NCT04415073 United States Phase 2 Randomized, Double-blind, Proportion of subjects alive and free of Recruiting High
Placebo-controlled. respiratory failure [ Time Frame: 29 Estimated Primary
Sponsor: Syndax Days ] Completion Date:
Pharmaceuticals N=186 adults hospitalized and November 15, 2020
confirmed COVID-19 randomized 1:1 to
xatilimab or matching placebo as an
add-on to SOC.
Canakinumab NCT04365153 United States, A phase 2, quadruple-blinded, Time to clinical improvement up to day Recruiting Medium
Ohio randomized controlled study to 14, defined as the time in days from
Sponsor: The Cleveland demonstrate as a proof of concept that randomization to either an Estimated Study
Clinic early treatment with canakinumab improvement of two points on a seven- Completion Date:
prevents progressive heart and category ordinal scale or discharge from December 31, 2020
respiratory failure in patients with the hospital, whichever occurs first. [
COVID-19 infection Time Frame: Up to day 14 ]
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Version of 16.06.2020
Sponsor: NYU Langone N=90, randomized 1:1:1 to
Health clazakizumab 12,5 mg
clazakizumab 25 mg or placebo
Clazakizumab NCT04348500 United States Phase 2, Parallel, Randomized, Blinded Incidence of need for mechanical Not yet recruiting Medium
clinical trial to Evaluate the Safety and ventilation and/or ECMO at 14 days Estimated Study
Sponsor: Cedars-Sinai Tolerability of Clazakizumab compared after the first administered dose in Completion Date:
Medical Center to placebo. comparison to placebo March 31, 2021
Expanded access
Eculizumab (Soliris) NCT04346797 France Phase 2, Bayesion, open-label, Survival without needs of intubation at Recruiting Medium
randomized trial on the efficacy and day 14 (Survival without needs of
Sponsor: Assistance safety of Eculizumab in patients with intubation, events considered are Estimated Primary
Publique - Hôpitaux de Covid-19 infection intubation or death) Completion Date: Sept
Paris 2020
N=120, age>18, with moderate, severe Change in organ failure at day 3
pneumonia or critical pneumonia due
to Covid-19
Randomized to IV Eculizumab
treatment or standard of care
Eculizumab NCT04355494 France Expanded Access to patients with Not applicable Available Low
Sponsor: confirmed diagnosis of SARS-CoV-2
Alexion Pharmaceuticals infection presenting as severe COVID-19
requiring hospitalization.
63
Version of 16.06.2020
Mavrilimumab NCT04337216 United States, Open label single arm study. Time to resolution of fever [ Time Not yet recruiting; Low
Not approved drug. Virginia N=10 patients with severe COVID-19 Frame: Up to 28 days ] Estimated Primary
Under development for and systemic hyper-inflammation Completion: July 2020
rheumatoid arthritis
IC14 (monoclonal antibody NCT04346277 Italy Compassionate use open label program Available Low
against CD14) in patients hospitalized with pulmonary
complications of SARS-CoV-2 infection
Sponsor: Implicit who will receive IC14
Bioscience
Product: EudraCT number: Italy Phase 2 Primary objective: Recruiting High
Mavrillimumab 2020-001795-15 A randomized, double-blind, placebo- To demonstrate the benefit of
controlled trial of MavrilimumaB for mavrilimumab vs placebo added to best Estimated primary
NCT04397497 Acute respiratory failure due To COVID- SOC in reducing the dependency on completion
Sponsor: 19 pneumonia with hyperinflammation: oxygen supplementation in patients September 22, 2020
IRCCS Ospedale San COMBAT-19 the COMBAT-19 trial with COVID-19 pneumonia and signs of
Raffaele – Milano Patients will be randomized in a 1:1 systemic hyperinflammation
Prof. Lorenzo Dagna ratio to either
mavrilimumab + standard of care or Primary endpoint:
placebo + standard of care Time to the absence of need for oxygen
supplementation (time to first period
N= 50 patients with COVID-19-induced of 24 hrs with a SpO2 of 94%) within
pneumonia and systemic day 14 of treatment, stated as Kaplan-
hyperinflammation Mayer estimates of the proportion of
patients on room air at day 14 and
Patients in the mavrilimumab arm will median time to room air attainment in
be dosed on Day 1 with a dose of 6 each arm.
mg/kg (using a
solution with a final concentration of
mavrilimumab of 50 mg/mL) infused IV
over
approximately 1 hour.
IL-2 (ILT101) NCT04357444 France, Paris Phase 2, double-blinded, placebo- The PaO2/FiO2 ratio at D7 [Time Frame: Not yet recruiting Medium
controlled, randomized trial on the use at Day7]
Sponsor: Assistance of a Low Dose of IL-2 In Acute Estimated Primary
Publique - Hôpitaux de Respiratory Distress Syndrome Related Completion: July 2020
Paris to COVID-19
64
Version of 16.06.2020
Ixekizumab and antiviral ChiCTR2000030703 China, Hunan A randomized, blinded, controlled, Lung CT [Time frame: Days 7 and 14] Recruiting Medium
therapy multicenter clinical trial.
City: Study execute time:
Sponsor: Changsha The trial is divided into two phases: 2020-03-10 to 2020-
Xiangya Hospital of Central Chasha 05-31
South University First stage
N=3 COVID-19 patients treated with
Ixekizumab plus antiviral therapy (α-
interferon nebulized inhalation,
lopinavir / ritonavir, chloroquine ,
Ribavirin, Abidol, but no more than 3).
The safety and efficacy were initially
observed for 7 days. 2.
Second stage
N=40 COVID-19 patients randomized
1:1 to Ixekizumab + antiviral therapy (α-
interferon nebulization inhalation,
lopinavir / ritonavir, chloroquine,
ribavirin, abidol, but no more than 3)
OR control group antiviral therapy (α-
interferon nebulized inhalation,
lopinavir / ritonavir, chloroquine,
ribavirin, abidol, but no more than 3).
65
Version of 16.06.2020
Olokizumab (OKZ), RPH- NCT04380519 Russia An International, multicenter, Proportion of patients, responded to Recruiting Medium
104 randomized, double-blind, adaptive the study therapy, in each of the
placebo-controlled study of the efficacy treatment groups [ Time Frame: Day 15 Estimated Primary
(IL6 inhibitor – not and safety of a single administration of ] Completion Date:
licensed) Olokizumab and RPH-104 with standard October 15, 2020
therapy in patients with severe SARS-
Sponsor: CoV-2 Infection.
R-Pharm International, LLC
N=372 subjects with laboratory-
confirmed SARS-CoV-2 infection and
COVID-associated respiratory
syndromes or bilateral changes in the
lungs typical for COVID-19, based on
chest computed tomography results.
66
Version of 16.06.2020
Tozumab + adamumab ChiCTR2000030580 Hubei, China Parallel intervention study, Several primary outcomes: chest CT, Recruiting; Low
(adalimumab?) http://www.chictr.org.c N=60 patients with severe or critical coronavirus detection, IL6 etc.
n/showproj.aspx?proj=5 covid-19 randomised to tozumab + From2020-02-01 To
0693 adamumab 2020-04-30
TJ003234 (Anti-GM-CSF NCT04341116 USA, Phase 1b/2, randomized, double-blind, 1. Proportion (%) of subjects Recruiting Medium
Monoclonal Antibody) multicenter placebo-controlled, multi-center trial. experiencing deterioration in clinical
status [ Time Frame: Changes from Estimated Primary
Sponsor: I-Mab Biopharma N= 144 patients with severe COVID-19 baseline on Day 14 ] Completion Date:
Co. Ltd under supportive care randomized to September 2020
TJ003234 3 mg/kg or TJ003234 6 mg/kg 2. Treatment Emergent Adverse Events
or placebo. [ Time Frame: Up to 30 days after drug
administration ]
vMIP ChiCTR2000029636 Hubei, China Single arm, case series. 2019-nCoV nucleic acid turning negative Recruiting; Low
viral macrophage time (from respiratory secretion), or the
inflammatory protein, http://www.chictr.org.c Moderate or severe covid-19 time to release isolation From2020-02-07 To
chemokine; n/showproj.aspx?proj=4 2020-07-3
Sponsor: Union Hospital, 9215
Tongji Medical College,
Huazhong University of
Science and Technology
Interferons
Product Study identifier Study location Study design Primary outcome Status of trial Importance
IFN beta-1a NCT02735707 Study sites Platform trial, adding IFN beta-1a The primary endpoint for all domains Recruiting; High
Traumakine across Asia- Traumakine to immune-modulatory will be all-cause mortality at 90 days
Licensed for ARDS REMAP-CAP link Pacific, Europe treatments domain. Estimated Primary
https://www.remapcap. and North N=7100 patients with community- Completion:
+ convalescent plasma org . America acquired pneumonia, including COVID- December 2021
The trial protocol: excluding US. 19 patients, who require ICU care for
https://www.remapcap. the support of organ functions REMAP-CAP is ongoing
org/protocol- Intervention: IV IFN beta-1a, IFN beta-1a
documents hydrocortisone treatments, and other Traumakine treatment
study treatment options. not yet recruiting
REMAP-CAP:
Randomized, Embedded,
Multifactorial Adaptive
Platform trial for
Community-Acquired
Pneumonia
Interferon Beta 1a EudraCT: 2020-001023- UK, at leading Phase 2 Randomised, double-blind, Change in condition measured using the Ongoing High
14 NHS respiratory placebo-controlled trial. Ordinal Scale for Clinical Improvement
SNG001 is an inhaled medicine Pilot phase with 100 COVID-19 patients during the dosing period. Estimated study
formulation of interferon- centres. In total 400 patients completion: May 2021
beta-1a
67
Version of 16.06.2020
Recruitment via WHO webpage. The Ordinal Scale for Clinical
Not licensed Improvement is a World Health
Sponsor: Synairgen Organisation recommended scale for
Research Limited use in COVID-19 trials.
Interferon beta 1a NCT04385095 United Phase 2, double-blinded, placebo- Ordinal Scale for Clinical Improvement Recruiting High
(SNG001) Kingdom: controlled, randomized trial on the [Time Frame: Day 1 to day 28]
Belfast, efficacy of inhaled SNG001 (IFN-β1a for Estimated Primary
Sponsor: Synairgen Birmingham, Nebulisation) for Covid-19 infection Completion Date:
Research Ltd. Bradford, Hull, August 31, 2020
Leicester, N = 400, with Covid-19 infection
Manchester, randomized to SNG001 or placebo
Nottingham,
Oxford,
Southampton
Peginterferon Lambda-1A NCT04354259 Canada, Ontario Phase 2, randomized, controlled, open- 1. Cohort A (Ambulatory) - Primary Not yet recruiting Medium
label, multicenter trial to evaluate the Efficacy Endpoint [ Time Frame: At day
Sponsor: effect of Peginterferon Lambda for the 8 ] The proportion of participants with Estimated Primary
University Health Network, treatment of COVID-19. negative SARS-CoV-2 RNA on Completion Date:
Toronto nasopharyngeal swab. August 1, 2020
N=140 adult patients with mild to 2. Cohort A (Ambulatory) - Primary
moderate COVID-19. Safety Endpoint [ Time Frame: Day 1 to
Day 15 ] Rate of combined treatment-
Initial enrolment in Ambulatory cohort emergent and treatment-related severe
(Cohort A) followed by a safety adverse events (SAEs).
assessment before initiation of 3. Cohort B (Hospitalized) - Primary
enrolment in the Hospitalized cohort Efficacy Endpoint [ Time Frame: At Day
(Cohort B). 15 ] The proportion of participants with
Ambulatory patients (Cohort A) with negative SARS-CoV-2 RNA on
confirmed COVID-19 deemed well nasopharyngeal swab.
enough for home isolation will be 4. Cohort B (Hospitalized) - Primary
randomized to receive a single Safety Endpoint [ Time Frame: Day 1 to
subcutaneous injection of Peginterferon Day 30 ] Rate of combined treatment-
lambda 180µg prior to discharge or no emergent and treatment-related severe
therapy. Patients will be followed adverse events (SAEs).
remotely with a home visit for a repeat
swab at Day 4 and 8.
Hospitalized patients (Cohort B) with
moderate COVID-19 will be enrolled
and randomized to Peginterferon
lambda 180µg on Day 1 and 8, or best
supportive care.
68
Version of 16.06.2020
Mavrilimumab NCT04399980 United States, Phase 2, multicenter, blinded, Proportion of subjects alive and off of Recruiting Medium
Ohio randomized placebo controlled study to oxygen at day 14 [ Time Frame: Day 14 ]
Sponsor: demonstrate that early treatment with Estimated Primary
The Cleveland Clinic mavrilimumab prevents progression of Completion Date: May
respiratory failure in patients with 31, 2021
severe COVID-19 pneumonia and
clinical and biological features of hyper-
inflammation.
Interferon beta-1b and NCT04350281 Hong Kong Open-label randomized controlled trial Time to negative NPS viral load [ Time Recruiting; Estimated Medium
Hydroxychloroquine N=80 patients hospitalised for Frame: 4 weeks ] Primary Completion:
virologically confirmed SARS-CoV-2 March 31, 2022
Sponsor: infection randomized to
The University of Hong interferon beta-1b and
Kong hydroxychloroquine, or
hydroxychloroquine
Interferon Beta 1a NCT04343768 Iran, Tehran Phase 4, open-label, randomized trial Time to clinical improvement [Time Completed; Medium
compared to Interferon investigating the benefits of Interferon Frame: From date of randomization
Beta 1b, both in Beta 1a compared to Interferon 1b on until 14 days later] Estimated Primary
combination with top of The Base Therapeutic Regiment Completion Date:
Hydroxychloroquine + in Moderate to Severe COVID-19. (Improvement of two points on the April 27, 2020
Lopinavir/Ritonavir WHO seven-category ordinal scale or
N=60, with COVID-19 discharge from hospital) Update: completed as
Sponsor: Shahid Beheshti of May 5, 2020
University of Medical Arm 1: Hydroxychloroquine + Lopinavir/
Sciences Ritonavir + Interferon Beta 1a
Arm 2: Hydroxychloroquine + Lopinavir/
Ritonavir + Interferon Beta 1b
Arm 3: Hydroxychloroquine + Lopinavir/
Ritonavir
69
Version of 16.06.2020
Peginterferon lambda alfa- NCT04344600 United States, A phase 2b prospective, randomized, Proportion of participants with no Not yet recruiting Medium
1a subcutaneous injection Maryland single-blind, parallel, controlled trial of evidence of SARS-CoV-2 infection [ Time
two weekly subcutaneous injections of Frame: Up to 28 days ] Estimated Study
Sponsor: Johns Hopkins lambda interferon alfa-1a versus Completion Date: June
University placebo for prevention of SARS-CoV-2 Time (days) to no detection of SARS- 2021
infection. CoV-2 in two upper respiratory samples
[ Time Frame: Up to 14 days ]
N = 164 non-hospitalized participants at
high risk for infection due to household
exposure to an individual with
coronavirus disease.
Pegylated interferon NCT04343976 USA, Phase 2, open-label, randomized, Undetectable COVID PCR at day 7 Not yet recruiting Low
lambda Massachusetts controlled trial. [ Time Frame: 1 week ] (estimated study start
May 1, 2020)
Sponsor: N=40 (20 inpatient subjects with mild- Estimated Primary
Raymond Chung, to-moderate symptomatic and 20 Completion Date:
Massachusetts General outpatient subjects with mildly October 1, 2020
Hospital symptomatic COVID-19)
Randomized to pegylated interferon
lambda (180 mcg subcutaneous
injection) or standard of care.
Recombinant Interferon NCT04379518 United States, Phase 1/2A, open-label, single-group 1.Incidence of adverse events (AEs) [ Not yet recruiting Low
Alfa-2b New York study of Rintatolimod and IFN-Alpha Time Frame: Up to 30 days post
Regimen treatment intiation ] Estimated Primary
Sponsor: Roswell Park 2.Reduction of progression of infection Completion Date :
Cancer Institute N = 80 cancer patients with mild or requiring hospitalization April 6, 2021
moderate COVID-19 infection 3.Reduction of acute respiratory
distress syndrome (ARDS)
4.30-day mortality
Interferon alpha-2a plus ChiCTR2000030922 Guangdong, N=30 patients with mild or normal type COVID-19 nucleic acid negative Recruiting; Low
ribavirin China COVID-19 randomised to long-acting conversion rate, causal mortality, all- 2020-02-26 To 2020-
interferon alpha-2a (135ug) + ribavirin cause mortality (week 12) 08-26
or arbidol + ribavirin
Interferon alfa1beta NCT04293887 Tongji Hospital, Early phase 1 Multi-center, randomised, Dyspnea, reduced SPO2, respiratory Not yet recruiting; Low
China open, blank-controlled, multi-stage rate Estimated primary
clinical study. completion date: June
30, 2020
N=328 patients with corona pneumonia
Interferon ChiCTR2000029638 Sichuan, China Multicenter randomised controlled Clinical symptoms, blood routine etc. Recruiting; Low
http://www.chictr.org.c trial.
n/showproj.aspx?proj=4 N=100 patients with moderate to From2020-02-03 To
9224 severe covid-19 randomised to 2020-08-01
nebulization of novel gene recombinant
super compound interferon or
70
Version of 16.06.2020
nebulization of alpha-interferon
Peginterferon Lambda-1a NCT04331899 US Randomised open label study of N=120 Duration of Viral shedding of SARS-CoV- Not yet recruiting; Low
outpatients with mild COVID-19. 2 Estimated Primary
Randomised to Peginterferon Lambda- Completion: May 31,
1a or standard of care 2021
Cerrokin (recombinant ChiCTR2000030480 Hubei, China Randomized, open, blank controlled Incidence of side effects Recruiting; Low
human interferon alpha http://www.chictr.org.c trial. rom2020-03-03 To
1beta) n/showproj.aspx?proj=5 N=332 with covid-19 randomised to 2020-07-03
0470 cerrokin or conventional treatment
Recombinant human ChiCTR2000030013 Hubei, China Preventive study Blood routine examination and chest Not yet recruiting; Low
interferon alpha 1b spray http://www.chictr.org.c N=450, highly exposed Medical staff CT.
n/showproj.aspx?proj=4 treated with interferon (N=300) or From2020-02-20 To
9796 nothing 2020-06-30
Novaferon ChiCTR2000029496 Huhan, China Randomised, open label controlled trial. Time to negative testing Recruiting Low
Recominant inteferon N=90 with covid-19 randomised to
http://www.chictr.org.c Novaferon,
n/showproj.aspx?proj=4 Kaletra, or
8809 Novaferon+ Kaletra
Inhalation of IFN-κ and ChiCTR2000030262 Shanghai, China Clinical study, design not described. Wide range of primary outcomes: viral Recruiting Low
TFF2 in treatment of nCo- http: load, clinical features, inflammation,
V-infected patients. //www.chictr.org.cn/sho Intervention: pulmonary imaging
wproj.aspx?proj=50136 one day treatment of IFN-κ and TFF2
(n=10)
two day treatment of IFN-κ and TFF2
(n=10)
control (n=10)
Interferon alfa1b NCT04320238 Hubei, China Non randomised study. new-onset COVID-19 Recruiting; Low
2 single arm groups stratified by risk Estimated primary
factors will receive treatment with nasal completion:
interferon alfa1b. The high risk group May 2020
will additionally be treated with
thymosin.
N=2944 medical staff
71
Version of 16.06.2020
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Ruxolitinib NCT04362137 France, Phase 3, randomized, double-blind, Proportion of patients who die, develop Not yet recruiting High
Germany, placebo-controlled, 29-day, multicenter respiratory failure [require mechanical
Sponsor: 2020-001662-11 Italy, study to assess the efficacy and safety ventilation] or require intensive care Estimated Primary
Novartis Pharmaceuticals Spain, of ruxolitinib + standard-of-care unit (ICU) care [ Time Frame: 29 days ] Completion Date: July
Incyte Corporation RUXCOVID United therapy, compared with placebo + 10, 2020
Kingdom, standard-of-care therapy, in patients
United States aged ≥12 years with COVID-19
pneumonia.
72
Version of 16.06.2020
Ruxolitinib 2020-001459-42 Denmark Single arm study of severly afflicted 30-days mortality Duration of trial: 9 Low
COVID-19 infected patients in respirator months
Sponsor: or in the time window with urgent need
Zealand University of respirator before intubation.
Hospital N= 40 allocated to ruxolitinib
Ruxolitinib NCT04355793 Not stated Expanded Access Program of Ruxolitinib Not applicable Available Low
Spons: Incyte Corporation for the Emergency Treatment of
Cytokine Storm From COVID-19
Infection
Ruxolitinib NCT04359290 Tyskland? Phase 2, single-arm, open-label trial Overall survival [ Time Frame: 28 days Not yet recruiting Low
to evaluate the efficacy and safety of after registration into trial ]
Sponsor: ruxolitinib in the treatment of patients To determine the efficacy of ruxolitinib Estimated Primary
Philipps University with COVID-19 severe pneumonia. measured by overall survival Completion Date:
Marburg Medical Center September 2020
Ruxolitinib will be administered p.o. or
by gavage feeding starting with 2 x
10mg bid dose at day 1 and can be
increased up to 2 x 15mg bid from day 2
to day 28 (max) (depending on platelet
counts and renal function).
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Version of 16.06.2020
Estimated Primary
Completion: June 1,
2020
Ruxolitinib NCT04337359 Not stated Expanded access. Not applicable Not applicable Low
Sponsor: Novartis Patients with Severe/Very Severe
Pharmaceuticals COVID-19 Illness
Ruxolitinib NCT04338958 Germany Phase 2, Single arm, non-randomized, Overall response rate in reversal of Not yet recruiting; Low
University open label study hyperinflammation [ Time Frame: day 7 Estimated Primary
Hospital Jena N=200 COVID-19 patients grade II/III after start of therapy ] Completion: January
31, 2021
Ruxolitinib + Simvastatin EudraCT: Spain Phase 2, open-label, controlled, Patients achieving a grade 5 or higher of Ongoing Low
2020-001405-23 randomized trial on Ruxolitinib + the WHO 7-point ordinal scale of
Sponsor: Fundación de Simvastatin in prevention and severity categorization for COVID-19 Trial registration: 13-
Investigación HM NCT04348695 treatment of respiratory failure of 04-2020
Hospitales COVID-19 [Time frame: 7 days]
Estimate of duration:
N=94, hospitalized COVID-19 infections 1 month
with 3 or 4 on the WHO 7-point scale
Estimated primary
2 arms: Ruxolitinib + Simvastatin or completion: 13-05-
standard of care 2020
Ruxolitinib NCT04361903 Italy ?? Observational, cohort, retrospective, Number of patients who avoid Not yet recruiting Low
monocentric, non-profit study. mechanical assisted ventilation in acute
Sponsor: RESPIRE Study respiratory distress syndrome in Estimated Primary
Azienda USL Toscana Nord N=13 SARS-CoV-2 COVID-19 patients patients with SARS-CoV-2 COVID-19 [ Completion Date: May
Ovest with rapid worsening of respiratory Time Frame: 15 days ] 24, 2020
parameters in the last 12 hours treated
with ruxolutinib, dosage of at least 20
mg x 2 / day in the first 48 hours.
Therapeutic Plasma NCT04374149 United States Phase 2, open-label, non-randomized Overall Response Rate (Defined as Not yet recruiting Low
Exchange, Ruxolitinib study on the Efficacy of Therapeutic greater than or equal to 33% decrease
Plasma Exchange (TPE) Alone or in in cytokine load in one-third or more Estimated Study
Sponsor: Prisma Health- Combination With Ruxolitinib in COVID- participants) [Time Frame: 14 days] Completion Date:
Upstate 19 Positive Patients With PENN Grade April 30, 2021
2, 3, 4 Cytokine Released Syndrome
(CRS)
74
Version of 16.06.2020
http://www.chictr.org.c N=70 High risk patients randomised to From2020-01-31 To
n/showproj.aspx?proj=4 Ruxolitinib + stem cell therapy, or 2020-12-31
9088 Conventional treatment
INC424 / Ruxolitinib NCT04414098 Argentina Phase 2 Experimental, open-label, Evaluate the efficacy of ruxolitinib in Not yet recruiting Low
prospective, single center, add-on the treatment of COVID-19 severe acute
Sponsor: Marcelo study, compared with an historical respiratory syndrome [ Time Frame: Estimated Primary
Iastrebner control arm. during 14 days after the Completion Date:
commencement of treatment ] August 15, 2020
N=100 adults with COVID-19 with
Respiratory rate ≥ 20/min O2 saturation
≤93% with FiO2 of 0.21.
Baricitinib (Olumiant)
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. Licensed.
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Baricitinib (Olumiant); NCT04320277 Tuscany, Italy, Phase 3 study The percentage of ICU admission Recruiting; Medium
Anti-JAK acting against Non-randomised study with historical Estimated Study
JAK1 and JAK2. controls. Completion: May 30,
N=60 allocated to baricitinib. 2020
Sponsor: Hospital of Prato Controls: patients admitted to hospital
the previous 2 weeks who were treated
with antiviral and/or
hydroxychloroquine.
Baricitinib EudraCT: 2020-001955- Pisa, Italy PoC, phase 2a study, randomized, Number of patients requiring invasive Not yet recruiting; Medium
42 parallel, open-label study ventilation after 7 and 14
Sponsor: Prof. Francesco N=126 allocated to baricitinib + SC vs. days
Menichetti NCT04393051 standard care
BARICIVID-19
Baricitinib and NCT04390464 United Kingdom A phase 4, randomised, open-label trial Time to incidence of the composite Recruiting Medium
Ravulizumab to assess the efficacy of the endpoint of: Death, Mechanical
TACTIC-R immunomodulatory agents Baricitinib ventilation, ECMO, Cardiovascular Estimated Primary
Sponsor: Cambridge and Ravulizumab as potential organ support, or Renal failure [ Time Completion Date: May
University Hospitals NHS treatments for COVID-19 disease Frame: up to Day 14 ] 7, 2021
Foundation Trust against Standard of Care alone.
75
Version of 16.06.2020
IRCCS Policlinico S. Matteo impairment (Berlin criteria) [ Time Estimated Primary
N=13 adult patients with a confirmed Frame: 8 days ] Completion Date:
SARS-CoV-2 pneumonia September 15, 2020
2. Response to treatment: survival [
Baricitinib 4 mg/day for 7 days Time Frame: 8 days ]
Baricitinib NCT04358614 Italy Phase 2/3, non-randomized, open-label To assess the safety of baricitinib Completed Low
retrospective study on the efficacy of combined with antiviral (lopinavir-
Sponsor: Fabrizio Cantini baricitinib compared with controls ritonavir) in terms of serious or non- Actual Study
(previously COVID-19 receving standard serious adverse events incidence rate. [ Completion Date:
therapy) Time Frame: 2 weeks ] April 7, 2020
76
Version of 16.06.2020
ventilation compared to
hydroxychloroquine alone.
77
Version of 16.06.2020
N=358 randomized to Pacritinib +
Sponsor: standard of care or placebo + standard
CTI BioPharma of care.
78
Version of 16.06.2020
United States
Dialyzable Leukocyte NCT04379479 Mexico A phase 2, randomized, placebo- Change in the score of the "Contingency Not yet recruiting High
Extract controlled, double-blinded study to scale to assess the severity of acute
(FUTURE-T) asses the clinical effect of dialyzable respiratory disease in cases Estimated Primary
Sponsor: National leukocyte extracts suspected/confirmed by COVID-19" [ Completion Date:
Polytechnic Institute, Time Frame: 35 days ] August 2020
Mexico N = 562 patients with symptoms of non-
severe acute respiratory infection
(suspected/confirmed cases of COVID-
19).
MSTT1041A (astegolimab) NCT04386616 United States, A phase 2, randomized, double-blind, Clinical Status, Assessed Using a 7- Not yet recruiting High
+ UTTR1147A California + placebo-controlled study to assess the Category Ordinal Scale [ Time Frame:
Pennsylvania efficacy and safety of MSTT1041A Day 28 ] Estimated Primary
MSTT1041A a fully human (astegolimab) or UTTR1147A in Completion Date:
monoclonal antibody combination with standard of care September 24, 2020
designed to inhibit binding (SOC) compared with matching placebo
of interleukin-33 (IL-33) to in combination with SOC
the ST2 receptor.
UTTR1147A, a human IL- N = 300 patients hospitalized with
22Fc (immunoglobulin G severe coronavirus disease 2019
(IgG)4) fusion protein, (COVID-19) pneumonia.
activates IL-22 signaling.
79
Version of 16.06.2020
SARS-CoV-2 infection to C3 complement
inhibitor (AMY-101) or placebo.
EB05 (IV, inhibitor of TLR4) NCT04401475 Not stated Phase 2 Randomized, Double-Blind, An improvement of two points on the Not yet recruiting High
Placebo-Controlled Study to Evaluate seven-point ordinal scale [ Time Frame:
Sponsor: Edesa Biotech the Safety and Efficacy of EB05 + SOC 28 days ] Estimated Primary
Inc. vs. Placebo + SOC in Adult Hospitalized The severity of COVID-19 related Completion Date:
Patients With Moderate to Severe respiratory disease is assessed on s September 2020.
COVID-19 Pneumonia. predefined seven-point ordinal scale
ranging from not hospitalized with
Standard of care plus single IV infusion resumption of normal activities to
of 15mg/kg of EB05. The study is death.
divided in 2 stages.
80
Version of 16.06.2020
Anakinra NCT04341584 France A phase 2, randomized, open label Survival without needs of ventilator Not yet recruiting Medium
clinical trial to evaluate the therapeutic utilization at day 14; WHO progression
Sponsor: Assistance effect and tolerance of Anakinra. scale ≤ 5; Cumulative incidence of Estimated Primary
Publique - Hôpitaux de successful tracheal extubation (defined Completion: May 2020
Paris N=240 patients with moderate, severe as duration extubation > 48h) or
pneumonia or critical pneumonia withdrawal of NIV or high flow (for >
associated with COVID-19. 48h), at day 14; Decrease of at least
one point in WHO progression scale
score
Anakinra NCT04364009 France? A phase 3, multicentre, open-label, Treatment success [ Time Frame: After Not yet recruiting Medium
randomized controlled to assess the 14 days of treatment ]
Sponsor: University (ANACONDA) efficacy of Anakinra + optimized Estimated Primary
Hospital, Tours Standard of Care (oSOC) as compared Completion Date:
to oSOC alone. September 10, 2020
81
Version of 16.06.2020
respiratory syndrome coronavirus 2
(SARS-CoV-2) at high risk for
progression to serious respiratory
failure
Anakinra and Ruxolitinib NCT04366232 France A phase 2, randomized, open-label Biological criteria [ Time Frame: 7 days Not yet recruiting Low
controlled study to evaluate the from enrolment ]
Sponsor: Centre efficacy and safety of anakinra and At least 3 parameters are met including Estimated Study
Hospitalier Intercommunal ruxolitinib compared to Standard of CRP and/or Ferritin among: Completion Date:
de Toulon La Seyne sur care a.CRP: decrease > 50% August 31, 2020
Mer b.Ferritinemia: decrease > 1/3
N = 50 c.Serum creatinine: decrease > 1/3
d.AST/ALT: decrease > 50%
e.Eosinophils > 50 /mm3
f.Lymphocytes > 1000 /mm3
Anakinra (anti il-1) EudraCT number: 2020- Spain A phase 2/3, randomized, open-label Treatment success, defined as number Ongoing Low
001825-29 clinical trial to assess the effect of of patients not requiring mechanical
Sponsor: anakinra in addition to standard ventilation by Day 15. Estimated Primary
NAVARRABIOMED - treatment on the need for mechanical Number of patients not requiring Completion Date:
FUNDACIÓN MIGUEL ventilation. mechanical ventilation (day 28). August 5, 2020
SERVET Time to mechanical ventilation (days)
N = 180 patients with severe COVID-19 Time to oxygen saturation
and CSS pneumonia. normalization
Stay in ICU and hospitalization (days)
Anti-Interleukin-8 (Anti-IL- NCT04347226 United States, Phase 2, open-label, randomized trial Time to Improvement in the 7-point Recruiting Medium
8) (BMS-986253) New York investigating the use of Anti-IL-8 in ordinal scale [Time Frame: 1 year]
cancer patients with Covid-19 infection Estimated Primary
Sponsor: Matthew Dallos Completion date:
N=138, age > 18, hospitalized cancer September 2021
patients with Covid-19 infection
randomized 2:1 to either BMS-986253
or standard of care
APL-9 (Complement (C3) NCT04402060 United States Phase 1/2 Randomized, Double-Blinded, Cumulative incidence of treatment- Not yet recruiting Medium
Inhibitor) Vehicle-Controlled, Multicenter, emergent serious adverse events and
Parallel-Group Study of APL-9 in Mild to treatment-emergent adverse events. [ Estimated Primary
Sponsor: Apellis Moderate Acute Respiratory Distress Time Frame: Day 1 through Day 21 ] Completion Date:
Pharmaceuticals, Inc. Syndrome Due to COVID-19. November 2020
82
Version of 16.06.2020
ArtemiC NCT04382040 Israel A phase 2, double-blind, placebo- 1.Time to clinical improvement, defined Recruiting Medium
controlled randomized controlled as a national Early Warning Score 2
A natural formulation clinical study designed to evaluate the (NEWS2) of </= 2 Maintained for 24 Estimated Primary
intended for immune- effect of artemic in patients diagnosed Hours in comparison to routine Completion Date: July
modulation. with COVID-19 treatment [ Time Frame: 24 hours ] 31, 2020
2.Percentage of participants with
Sponsor: MGC N = 50 patients diagnosed with COVID- definite or probable drug related
Pharmaceuticals d.o.o 19 randomized in a manner of 2:1 for adverse events [ Time Frame: 14 days ]
study drug (ArteminC) and Standard of
Care to Placebo and Standard of Care.
Bemcentinib Not yet registered at UK, 6 Depts. A multicentre, seam-less, Phase II Safety and efficacy, not specified in the To start imminently Low
a once-a-day, oral, highly clin.trial or in Eu. adaptive randomization, for the press-release
selective and potent Platform trial to treatment of COVID-19 in hospitalised End of April 2020
inhibitor of AXL kinase The ACCORD study is assess multiple UK NHS patients.
mentioned in the Press- candidate N=120, 60 active Bemcentinib. 60 SOC
Not authorized. Ongoing release 28.04.2020 (link agents, the first
develop-ment in cancer, below in email) of which is
immune disease bemcentinib
Part of UK Fast track-
program
https://www.clinicaltrial
sarena.com/news/uk-
clinical-trials-covid-19-
drugs/
Conestat alfa NCT04414631 Switzerland Phase 2 Randomized, open-label, Disease severity on the 7-point Ordinal Not yet recruiting Medium
(Recombinant Human C1 parallel-group, controlled, multi-center World Health Organization [ Time Estimated Primary
Esterase Inhibitor) clinical trial. Frame: on day 7 ] Completion Date: June
2021.
Sponsor: University N=120 adults with confirmed COVID-19.
Hospital, Basel, 72 Hour treatment with conestat alfa in
Switzerland addition to SOC compared to SOC.
Cyclosporine (+ standard 2020-001262-11 Spain Phase 4, open-label, controlled, Proportion of patients in a non-serious Ongoing Low
treatment) randomized trial on the efficacy of category at 12 days of treatment
NCT04392531 cyclosporine in addition to standard Start date: 2020-04-09
Sponsor: Instituto de treatment compared to standard
Investigación Sanitaria treatment only Estimate of duration:
Fundación Jiménez Díaz 2 months
N=120 with confirmed COVID-19
infection Estimated Primary
Completion: July 2020
Degarelix NCT04397718 United States, A phase 2, multicenter, double-blinded, A composite endpoint of mortality, Not yet recruiting Medium
multiple sites placebo-controlled, randomized ongoing need for hospitalization, or
Sponsor: VA Office of controlled trial of best supportive care requirement for mechanical Estimated Primary
Research and (BSC) vs BSC plus degarelix. ventilation/extracorporeal membrane Completion Date:
Development oxygenation (ECMO) at Day 15 after October 1, 2020
randomization. [ Time Frame: 15 days ]
83
Version of 16.06.2020
N = 198 veterans with COVID-19
requiring hospitalization
Duvelisib NCT04372602 United States, A phase 2, open-label, non-randomized Overall survival [ Time Frame: Through Not yet recruiting Low
Missouri pilot study of Duvelisib to combat 28 days ]
Sponsor: Washington COVID-19 Estimated Study
University School of Completion Date:
Medicine N = 25 December 31, 2021
Etoposide NCT04356690 Not stated A phase 2, non-randomized, open label Change in pulmonary status [ Time Not yet recruiting Low
study designed to evaluate the safety Frame: baseline, through study
Sponsor: Boston Medical and efficacy of etoposide compared to completion, an average of 45 days ] Estimated Study
Center no intervention Completion Date:
December 2021
N = 134 patients that are either on
ventilation or not on ventilation
Fingolimod NCT04280588 Wan-Jin Chen Phase 2, not randomised, single arm The change of pneumonia severity on X- Recruiting; Low
Sponsor: First Affiliated N=30 with severe covid19 ray images
Hospital of Fujian Medical Estimated study
University completion:
July 1, 2020
Granulocyte colony- ChiCTR2000030007 Guangdong and Randomised controlled trial, N=200 Clinical symptoms Not yet recruiting; Medium
stimulating factor http://www.chictr.org.c Hubei, China with mild to severe covid-19 and low
n/showproj.aspx?proj=4 white blood cell count and low From2020-02-03 To
Sponsor: The First 9619 lymphocyte count 2020-04-10
Affiliated Hospital of
Guangzhou Medical
University
Ibrutinib NCT04375397 Not stated A phase 2, randomized, double-blinded, Percentage of Participants Alive and Not yet recruiting Medium
placebo-controlled study to evaluate if Without Respiratory Failure [ Time
Sponsor: AbbVie Ibrutinib is safe and can reduce Frame: Day 28 ] Estimated Primary
respiratory failure. Completion Date: July
30, 2020
N = 46 patients hospitalized for COVID-
19 infection and pulmonary distress
IC14 NCT04391309 United States, Phase 2, multicenter, randomized, Acute respiratory failure [ Time Frame: Not yet recruiting Medium
Washington double-blind, placebo-controlled study Day 1-22 ]
Sponsor: COV04 of IC14 (antibody to CD14) in reducing Estimated Primary
Implicit Bioscience the severity of respiratory disease in Completion Date: July
hospitalized COVID-19 patients. 2021
84
Version of 16.06.2020
Interleukin-7 NCT04379076 UK? A phase 2, randomized, double-blinded Improvement of the absolute Not yet recruiting Medium
placebo-controlled study of lymphocyte count (ALC) of lymphopenic
Sponsor: Revimmune recombinant interleukin-7 (CYT107) for (ALC≤1000/mm3) COVID-19 infected Estimated Primary
immune restoration participants out to approximately 30 Completion Date:
N = 48 hospitalized lymphopenic days following initial Study drug October 30, 2020
patients with coronavirus COVID-19 administration or Hospital discharge
Infection (HD), whicheve [ Time Frame: 1 month ]
Recombinant Interleukin-7 NCT04407689 France Phase 2, Multicenter, Randomized, Improvement of the absolute Not yet recruiting Medium
(CYT107) Belgium Double-blinded Placebo-controlled lymphocyte count (ALC) of lymphopenic
ILIAD-7-FR Study of Recombinant Interleukin-7 (ALC≤1000/mm3) COVID-19 infected Estimated Primary
Sponsor: (CYT107) for Immune Restoration of participants out to approximately 30 Completion Date:
Revimmune Hospitalized Lymphopenic Patients days following initial Study drug October 30, 2020
With Coronavirus COVID-19 Infection in administration or Hospital discharge
France and Belgium (HD), whichever occurs first [ Time
Frame: 1 month ]
N=48 patients (age 25-80 years of age)
randomized 1:1 to InterLeukin-7 or
placebo.
Jakotinib ChiCTR2000030170 Shanghai, China Single arm treatment stratified by Time to clinical improvement / time to Recruiting; Low
http://www.chictr.org.c severity, N=16 clinical recovery
n/showproj.aspx?proj=5 Time window: 28 days From2020-02-15 To
0017 2020-07-31
Lenalidomide NCT04361643 Spain Phase 4, double-blind randomized Clinical improvement [ Time Frame: 30 Not yet recruiting Medium
controlled clinical trial of low-dose days ]
Sponsor: Lenalidomide in the treatment of Estimated Primary
Hospital Universitario COVID-19. Immune-inflammatory improvement [ Completion Date:
Getafe Time Frame: 30 days ] August 31, 2020
N=120 subjects > 60 diagnosed or
clinical symotoms of covid-19
randomized to Lenalidomide or
placebo.
LEUKINE® (sargramostim) EudraCT Number: 2020- Belgium A prospective, randomized, open-label, Oxygenation after 5 DAYS through Ongoing; Medium
A recombinant human 001254-22 interventional study assessment of pretreatment (day 0) and Estimated Primary
granulocyte-macrophage post-treatment (day 5) ratio of Completion: October
colony stimulating factor NCT04326920 N=80 COVID-19 patients with acute PaO2/FiO2 and through measurement 31, 2020
(rhu GM-CSF) hypoxic respiratory failure randomised of the P(A-a) O2 gradient
FDA approved drug. to
Sponsor: University Leukine or
Hospital Ghent standard care.
Leukine® (Sargramostim - NCT04400929 Not stated Phase 2 randomized, double-blind, Measuring oxygenation [ Time Frame: Not yet recruiting Medium
GM-CSF) placebo-controlled clinical trial of iv Day 1 to Day 6 ]
Leukine® in 30 patients with confirmed To measure the effectiveness of Estimated Primary
Sponsor: Singapore COVID-19 and acute hypoxic respiratory Leukine® in restoring lung homeostasis, Completion Date: June
General Hospital failure. the primary endpoint of this 2021
intervention is measuring oxygenation
after 5 days of intravenous treatment
85
Version of 16.06.2020
N=30 confirmed with COVID-19, 15 will through assessment of pre-treatment
receive Leukine® + SOC and 15 will and post-treatment ratio of PaO2/FiO2,
receive placebo + SOC. and through measurement of the P(A-
a)O2 gradient, which can easily be
performed in the setting of clinical
observation of inpatients.
Sargramostim NCT04411680 Not stated Phase 2, randomized, open-label study 1. Change in oxygenation parameter of Not yet recruiting Medium
to determine if inhaled sargramostim, P(A-a)O2 gradient by Day 6 [ Time
Sponsor: iLeukPulm as an adjunct to institutional standard Frame: 1-6 days ] Estimated Primary
Partner Therapeutics, Inc. of care, improves clinical outcomes in Completion Date:
hospitalized patients with COVID-19- 2. Percent of patients who have been October 2020
associated acute hypoxemia. intubated by Day 14 [ Time Frame: 1-14
days ]
N=60 randomized 2:1 to sargramostim
plus standard of care or standard of
care alone
Melphalan NCT04380376 Russian A phase 2, non-randomized, open-label 1.The changes of COVID Ordinal Recruiting Low
Federation study to evaluate the efficacy, safety of Outcomes Scale [ Time Frame: baseline
Sponsor: Federal State inhalations of low-doses of melphalan vs Day 14, day 28 ] Estimated Primary
Budgetary Institution, 2.Percentage of the patients with Completion Date:
Pulmonology Scientific N = 60 patients with pneumonia with Clinical Recovery [ Time Frame: baseline October 30, 2020
Research Institute confirmed or suspected COVID-19. vs day 7, day 14, day 28 ]
3.The changes of the Borg's scale [ Time
Frame: Baseline vs day 7, day 14, day 28
]
Methotrexate (MTX) NCT04352465 Brasilien Phase I/II, Non-Randomized, open- Change in clinical conditions [ Time Not yet recruiting Low
label, to evaluate the efficacy and Frame: 21 days ]
Sponsor: safety of MTX-loaded nanoparticles in Clinical condition will be measured by Estimated Primary
Azidus Brasil three different doses to treat severe lung injuries Completion Date: June
COVID-19 patients. 30, 2020
N=42
86
Version of 16.06.2020
Nintedanib (Ofev) NCT04338802 Not stated Open label, randomized, Placebo- Changes in forced vital capacity (FVC) [ Not yet recruiting; Medium
Indicated for idiopatic controlled Study. Time Frame: 8 weeks ] Estimated Primary
pulmonary fibrosis N=96 with COVID-19 randomised to Completion: May 4,
Nintedenib or placebo 2020
Sponsor:
Huilan Zhang
Nintedanib ChiCTR2000031453 China, Hubei Phase 4, Single-center, randomized, FVC, DLco%, 6MWT, HRCT score and Not yet recruiting High
parallel, placebo-controlled clinical trial change in cough
Sponsor: Tongji Hospital of to evaluate the efficacy and safety of From 2020-04-02 To
Tongji Medical College, Nintedanib esilate soft capsules in the 2020-08-01
Huazhong Science and treatment of pulmonary fibrosis in
Technology University patients with moderate to severe
COVID 19.
87
Version of 16.06.2020
http://www.chictr.org.c N=40, randomised to From2020-02-11 To
n/showproj.aspx?proj=4 Polyinosinic:polycytidylic acid or 2020-12-31
9342 conventional therapy
Pirfenidone ChiCTR2000030892 Guangdong, Open label, prospective exploratory HRCT pulmonary fibrosis score Recruiting; Low
China experimental medical study Duration: from 2020-
N=40 patients with severe post-COVID- 03-06 to 2020-12-30
19 fibrosis randomized to pirfenidone
or no intervention
Pirfenidone ChiCTR2000031138 China, Hu'nan A multicenter, prospective, randomized HRCT score Recruiting Low
controlled trial to investigate the
Sponsor: The third xiangya therapeutic effect of the anti- From 2020-03-01 To
hospital of Central South inflammatory and antifibrotic drug 2020-12-31
University pirfenidone compared to support
treatment
Plitidepsin NCT04382066 Spain A phase 1, randomized, open-label 1.Frequency of occurrence of Recruiting Low
study to evaluate the safety profile of Neutropenia ≥ grade 3
Sponsor: PharmaMar three doses of plitidepsin 2.Frequency of occurrence of Estimated Primary
Thrombocytopenia ≥ grade 3 Completion Date:
N = 27 patients with COVID-19 requiring 3.Frequency of occurrence of Anemia ≥ November 2020
hospitalization grade 3
4.Frequency of occurrence of
Lymphopenia ≥ grade 3
5.Frequency of occurrence of CPK
increase ≥ grade 3
6.Frequency of occurrence of Increase
ALT and / or AST ≥ grade 3
7.Frequency of occurrence of Increase
total bilirubin or direct bilirubin ≥ grade
3
8.Frequency of occurrence of
Neurotoxicity ≥ grade 3
9.Frequency of occurrence of QT-QTc
interval extension ≥ grade 3
10.Frequency of occurrence of Other
adverse events ≥ grade 3
11.Percentage of patients in whom
treatment cannot be completed.
12.Percentage of patients with adverse
events.
13.Percentage of patients with serious
adverse events.
14.Percentage of patients with ECG
abnormalities.
88
Version of 16.06.2020
Product: EudraCT number: Italy Phase 2/3 Proportion of patients not on Best guess not started Medium
pamrevlumab 2020-001472-14 An open label randomised 1:! Parallel ventilatory support 15 days Recruiting yet
arm study investigating the efficacy and
safety of intravenous administration of Estimated primary
Sponsor: pamrevlumab versus standard of care in completion
Prof. Luca Richeldi MD PhD patients with COVID-19 July/August 2020
Professor of Respiratory
Medicine N=65 hospitalized covid-19 patients
Fondazione Policlinico requiring supplemental oxygen, but not
Universitario A. Gemelli ventilation, randomised 1:1
IRCCS
Università Cattolica del Pamrevlumab dosing, 30 mg/kg IV, will
Sacro Cuore be administered at day 1, day 7 and day
14.
and
FibroGen, Inc.
Recombinant human ChiCTR2000030 Hubei, China Randomised, controlled trial. Blinding Fatality rate, and CD8+, CD4+ and NK Not yet recruiting; Low
Interleukin-2 http://www.chictr.org.c not stated. cells From2020-03-02 To
n/showproj.aspx?proj=4 N=80 randomised to 2020-09-01
9567 167 Recombinant Human Interleukin-2, or
placebo
Selinexor NCT04349098 Global trial with Interventional, randomized, parallel Percentage of Participants with at Least Not recruiting Medium
sites in US, assignment, single-blind study a 2 Point Improvement in the Ordinal
Oralselective inhibitor of EudraCT: 2020-001411- Europe and N=230 Scale [Time Frame: Estimated study start:
nuclear export (SINE) 25 Israel 18 years and above Baseline to Day 14] April 30, 2020
which bloks the cellular Evaluate the activity and safety of low
protein XPO1 XPORT-CoV-1001 dose oral Selinexor (KPT-330 or Estimated primary
XPOVIO) in patients with severe COVID- completion data:
Approved by FDA for 19 infection Aug 31, 2020
heavily pretreated Phase II
multiple myeloma Treatment 3 times daily for 2 weeks
Sponsor:
Karyopharm Therapeutics
Inc
Selinexor NCT04355676 Not stated Phase 2 Randomized, Open-Label, Percentage of Participants with at Least Not yet recruiting; Low
Multicenter Study. a 2 Point Improvement in the Ordinal Estimated Primary
Sponsors and N=80 patients with moderate or severe Scale [ Time Frame: Baseline to Day 14 ] Completion:August
Collaborators COVID-19 ranomised to selinexor 20 mg 30, 2020
Karyopharm Therapeutics every second day or selinexor 40 mg
Inc every second day
Sirolimus NCT04341675 United States, Phase 2 randomized, double-blind, Progression to advanced respiratory Recruiting Medium
Ohio, University placebo-controlled study of Sirolimus support in patients treated with
Sponsor: University of of Cincinnati Treatment in Hospitalized Patients With Sirolimus vs placebo
Cincinnati COVID-19 Pneumonia (SCOPE)
89
Version of 16.06.2020
Estimated primary
N=30 completion date: July
2020
Randomized 2:1 to
Sirolimus 6mg oral on day 1 followed by
2mg daily for max 14 days or until
hospital discharge or placebo
Sirolimus NCT04371640 United States, A phase 1, double-blinded, randomized, Change in SARS-CoV-2 viral burden from Recruiting Medium
Pennsylvania placebo controlled study comparing the baseline to day 7 of treatment [ Time
Sponsor: Walter K. Kraft virological efficacy of add-on sirolimus Frame: Baseline, and days 1, 2, 3, 4, 5, Estimated primary
with standard care to placebo and 6, & 7 post-dose for all patients ] Completion Date:
standard care. August 2020
N = 40
TD-0903 NCT04350736 United Kingdom A Phase 1, Double-blind, Randomized, Safety and Tolerability of SAD of TD- Not yet recruiting; Medium
Inhaled Placebo-controlled, Sponsor-open, 0903: Adverse Events [ Time Frame: Day Estimated Primary
TD-0903 is a lung- single ascending dose and multiple 1 to Day 8 ] Completion: June
selective, nebulized Janus ascending dose study. 2020
kinase inhibitor in N=54 healthy volounteers randomized Safety and Tolerability of MAD of TD-
development for the to TD-0903 or placebo in different 0903: Adverse Events [ Time Frame: Day
potential treatment of cohorts of single or multiple doses 1 to Day 14 ]
hospitalized patients with
Acute Lung Injury caused
by COVID-19.
Sponsor:
Theravance Biopharma
TD-0903 NCT04402866 United Kingdom Phase 2, randomized, double-blind, 1. Part 2: SaO2/FiO2 ratio [ Time Frame: Not yet recruiting Medium
placebo-controlled, parallel-group, Baseline, Day 7 ]
Sponsor: 2020-001807-18 multi-center study of an inhaled Pan- Estimated Primary
Theravance Biopharma Janus Kinase Inhibitor, TD-0903, to treat 2. Part 2: Ventilator-free Days (VFDs) [ Completion Date:
symptomatic acute lung injury Time Frame: Baseline through Day 28 ] October 2020
associated with COVID-19.
N=159
Part 1 (n=24)
Cohort: MAD Dose A, MAD Dose B and
MAD Dose C.
6 out of 8 subjects per cohort will be
randomized to receive the TD-0903
dose.
2 out of 8 subjects per cohort will be
randomized to receive placebo.
Part 2 (n=135)
N=135 randomized 1:1:1 to TD-0903
dose A, TD-0903 dose B or placebo.
90
Version of 16.06.2020
Tranilast, novel NLRP ChiCTR2000030002 Anhui, China Open label study; Cure rate Recruiting; Low
Inflammasome inhibitor.
Used for the prevention of http://www.chictr.org.c N=60 randomised to tranilast or From2020-02-15 To
scarring post glaucoma n/showproj.aspx?proj=4 vonventional therapy 2020-07-30
filtration surgery. 9738
Has previously been
approved in Japan and
South Korea for bronchial
asthma, keloid and
hypertrophic scar.
Thymosin ChiCTR2000029806 Not stated N=120 with severe covid-19 and Proportion of patients with a lung injury Recruiting; Medium
lymphocytopenia randomised to score reduction of 1-point or more 7
Sponsor: Wuhan Jinyintan http://www.chictr.org.c PD-1 ( PD-1 and thymosin), days after randomization From2020-01-01 To
Hospital (Wuhan Infectious n/showproj.aspx?proj=4 thymosin, or 2021-01-31
Diseases Hospital) 9161 conventional treatment
Thalidomide NCT04273581 China Prospective, Multicenter, Randomised, Time to Clinical Improvement (TTCI) Not yet recruiting; Medium
Sponsor: First Affiliated Double-blind, Placebo, Parallel (Time Frame: up to 28 days)
Hospital of Wenzhou Controlled Clinical Study Primary completion
Medical University date: April 30, 2020
N=40, Severe Covid-19 randomised to
thalidomide
or placebo
Thalidomide; NCT04273529 China Phase 2 study, prospective, Multicenter, Time to Clinical Recovery (TTCR) (Time Not yet recruiting, Medium
Sponsor: First Affiliated Randomised, Double-blind, Placebo, Frame: up to 28 days) Estimated primary
Hospital of Wenzhou Parallel Controlled Clinical Study completion date: June
Medical University 30, 2020
N=100 moderate Covid-19 randomised
to thalidomide, or
placebo
NK cells NCT04280224 China, Henan Phase 1 Improvement of clinical symptoms Recruiting; Low
including duration of fever, and Estimated primary
N=30 with covid19 randomised to respiratory frequency completion date: Sep
NK cells, or 30, 2020
Conventional treatment Adverse reactions
NK cells ChiCTR2000031735 China, Zheijang Phase 0, parallel, interventional study Monitoring of adverse events within 24 Not yet recruiting Low
to evaluate the safety and efficacy of hours after infusion, Recovery time,
Sponsor: Huzhou Central cord blood NK cells in the treatment of Virus nucleic acid negative time and From 2020-03-01 To
Hospital new coronavirus and other viral rate, The rate and time of main 2021-02-28
pneumonia patients. symptoms disappear, Pulmonary
imaging changes, Arterial oxygen partial
N = 20 aged 18 years old diagnosed pressure and oxygenation index were
with new coronavirus to NK cells were measured 2 days after infusion, Blood
injected by intravenous drip once a day RT, Serum inflammatory factors
for 2 to 3 times in total, each dose was
4 10^7 pieces /kg body weight,100ml
91
Version of 16.06.2020
normal saline suspension or 100ml
normal saline intravenous drip.
Umbilical cord blood CIK ChiCTR2000030329 Shaanxi, China N=90 patients with mild to moderate Status of immune function Not yet recruiting Low
(cytokine induced killer) http://www.chictr.org.c covid-19 and poor immune function Time of nucleic acid turns to negative From2020-03-01 To
and NK (natural killer) cells n/showproj.aspx?proj=4 randomised 1:1:1 to Length of hospital stay 2021-02-17
9779 Umbilical cord CIK cells,
Umbilical cord NK cells, or
Conventional treatment
NK cells, NCT04324996 China A Phase I/II Study of Universal Off-the- Clinical response Recruiting; Medium
IL15-NK cells, NKG2D CAR- shelf NKG2D-ACE2 CAR-NK Cells Safety and tolerability Estimated Primary
NK cells, N=90 randomised to 5 different Completion: May 31,
ACE2 CAR-NK cells, treatments of NC-cells 2020
NKG2D-ACE2 CAR-NK cells
Allogeneic NK transfer NCT04344548 Colombia Phase 1/2 open label clinical trial to Adverse effects and Safety [ Time Not yet recruiting Low
evaluate the safety and immunogenicity Frame: 3 months ]
Sponsor: Universidad of allogeneic NK cells from peripheral Estimated Primary
Nacional de Colombia blood mononuclear cells (PBMCs) of completion : June 10,
healthy donors in patients infected with 2020
COVID-19.
92
Version of 16.06.2020
Viral Specific T-cells will be infused into
study participants who have evidence
of SARS-CoV-2 infection.
Zanubrutinib NCT04382586 United States, A phase 2, randomized, double blind, Respiratory failure-free survival rate at Not yet recruiting Medium
several placebo-controlled study of day 28 [ Time Frame: 28 Days ]
approved for the locations zanubrutinib treatment Estimated Primary
treatment of mantle cell Completion Date: July
lymphoma in the United N = 52 patients hospitalized for COVID- 2020
States 19 infection and pulmonary distress
Sponsor: BeiGene
Zilucopla NCT04382755 Belgium A phase 2, randomized, open-label, 1.Mean change in oxygenation [ Time Not yet recruiting Medium
placebo-controlled study to investigate Frame: at predose, day 6 and day 15 (or
Complement inhibitor, not the efficacy of complement c5 at discharge, whichever comes first) ] Estimated Primary
licensed inhibition with zilucoplan in improving 2.Median change in oxygenation [ Time Completion Date: May
oxygenation and short-and long-term Frame: at predose, day 6 and day 15 (or 2021
Sponsor: University outcome of COVID-19 at discharge, whichever comes first) ]
Hospital, Ghent
N = 81 COVID-19 patients with acute
hypoxic respiratory failure
Anti-inflammatory drugs
Leflunomide ChiCTR2000030058 Hubei Phase 3, multicenter, randomized, The days from positive to negative for Not yet recruiting; High
double-blind, controlled clinical trial viral nucleic acid testing
Approved in EU for
http://www.chictr.org.c N=200 patients with pneumonia caused From2020-03-01 To
rheumatoid arthritis and
n/showproj.aspx?proj=4 by novel coronavirus. randomised to 2020-05-30
psoriasis arthritis
9831 Leflunomide,
or placebo
Sponsor: Renmin Hospital
of Wuhan University
93
Version of 16.06.2020
Leflunomide NCT04361214 United States, Phase 1, open-label, non-randomized 1.Tolerability of high dose leflunomide Not yet recruiting Low
Illinois tolerability study of high dose as measured by leflunomide dose
Sponsor: University of leflunomide therapy in outpatient adult modifications Estimated Study
Chicago participants with mild COVID-19 Completion Date: July
2.Tolerability of high dose leflunomide 2020
N = 20 patients with COVID-19 who are as measured by discontinuation of
not yet hospitalized, but have risk leflunomide
factors for disease progression and
complications. 3.Tolerability of high dose leflunomide
as measured by Adverse Events
Leflunomide ChiCTR2000033372 China, Hubei Non-randomized study to evaluate the SARS-CoV-2 clearance Completed Low
safety and efficacy of leflunomide for
Sponsor: the treatment of refractory COVID-19 in From 2020-03-12 To
Shandong University Qilu adult patients 2020-05-17
Hospital
Retrospective registration
94
Version of 16.06.2020
N=240 adult patients hospitalized for 3. Ultrasensitive troponin on the fifth
COVID pneumonia and day of treatment.
hyperinflammation randomized to
Colchicine
or ??
Colchicine NCT04416334 Spain Phase 3, randomized, single-center, 1. Number of participants who die due Active, not recruiting Medium
open-label, controlled trial to evaluate to COVID-19 infection [ Time Frame: 21
Sponsor: COLCHICOVID efficacy and safety of early days post-randomization ] Estimated Primary
Instituto de Investigación administration of colchicines in patients Completion Date:
Marqués de Valdecilla older than 70 years, with high risk of 2. Number of participants who require September 25, 2020
pulmonary complications due to COVID- hospitalization due to COVID-19
19). infection [ Time Frame: 21 days post-
randomization ]
N=1028 randomized to colchicine +
symptomatic treatment (paracetamol)
or symptomatic treatment alone.
Colchicine, Ruxolitinib and NCT04403243 Russia Phase 2, randomized, open-label study. Change from baseline in clinical Recruiting Medium
Secukinumab assessment score COVID 19 (CAS COVID
COLORIT N=70 patients with mild and severe 19) Frame: baseline [ Time Frame: Estimated Primary
Sponsor: COVID-19 randomzied 3:1:1:3 to baseline, day 12 ] Completion Date: July
Lomonosov Moscow State colchicine, ruxolitinib, secukinumab and 22, 2020
University Medical control group (standard of care)
Research and Educational
Center
Colchicine NCT04367168 Mexico Phase 2, double-blinded, placebo- Temperature, myalgia, arthralgia, total Not yet recruiting Medium
controlled, randomized trial on the use lymphocyte count, D-dimer, fibrinogen
Sponsor: Instituto Nacional of Colchicine in mild and severe Covid- and ferritin levels [Time Frame: Up to
de Ciencias Medicas y 19 infection 24 days]
Nutricion Salvador Zubiran
N = 174, Age ≥ 18, diagnosed with 2.Progression to severe disease [Time
Covid-19 with mild or severe disease Frame: Up to 10 days]
receiving in-hospital care
Colchicine, Herbal Phenolic NCT04392141 Iran Phase 1/2, randomized, double-blinded Mortality rate [ Time Frame: up to 30 Recruiting Low
Monoterpene Fractions trial. days ]
Estimated Primary
Sponsor: N=200 subjects (10 years or older) with Completion Date: June
Kermanshah University of COVID-19 based on laboratory and/or 1, 2020
Medical Sciences radiological and clinical manifestation
randomized to Colchicine + Herbal
Phenolic Monoterpene Fractions or
standard treatment.
Colchicine 2020-001511-25 Spain Randomized open-label controlled trial Ordinal 7-point clinical evaluation scale; Start date: 2020-04-14 Low
N= 102 patients with COVID-19 IL-6 concentration Estimated duration 6
NCT04350320 randomized to months
COL-COVID Colchicine.
Comparator not stated
95
Version of 16.06.2020
Colchicine ClinicalTrials.gov Italy, Randomized, controlled, open-label, Clinical improvement [Time Frame: Day Estimated study start Low
Identifier: NCT04322565 Multicentre in trial. 28] date April 20, 2020.
Colchicine Efficacy in N= 310 patients randomised to Time to clinical improvement: defined Estimated primary
COVID-19 Pneumonia colchicine + standard or standard as time from randomization to an completion June 20
EudraCT: 2020-001258- treatment improvement of two points from the 2020
23 status at randomization on a seven-
category ordinary scale
96
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Cholchicine 2020-001603-16 Spain Phase 3, randomized, multicentre, Number of participants who die or Ongoing Medium
open-label, controlled trial to require hospitalization due to 19-COVID
Sponsor: COLCHI-COVID investigate the effectiveness of early infection within 30 days of Estimated primary
IDIVAL Cholchicine administration in patients randomization completion: 2020-08-
over 70 years of age with high risk of 08
developing severe pulmonary
complications associates with SARS-
CoV2 pneumonia.
97
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Inhaled Hypertonic NCT04382768 Argentina An open-label expanded compassionate 1.Change in the scale of ordinary COVID Enrolling by invitation Low
ibuprofen use program for patients infected with results at 7, 14 and 28 days in patients
SARS-CoV-2 to evaluate the reduction in with acute respiratory infection, Estimated Primary
Sponsor: Química Luar SRL severity and progression of lung injury induced by SARS-CoV-2, treated with Completion Date:
with inhaled ibuprofen inhaled Ibuprofen. [ Time Frame: 7, 14 January 2021
and 28 days ]
N = 40 patients with severe acute 2.Change to Negativization of the swab
respiratory syndrome due to SARS-CoV- to the following treatment points on
2 virus. day 7, day 14, 21 and 28 after
treatment with inhaled Ibuprofen. [
Time Frame: 7, 14 and 28 days ]
Celebrex ChiCTR2000031630 China, Phase 0 non randomized clinical study Prostaglandin E2 Recruiting Low
Guangdong for Celebrex in the treatment of novel
Sponsor: Guangzhou coronavirus pneumonia (COVID-19). From 2020-02-17 To
Eighth People's Hospital 2020-06-17
N = 60 age > 18 with confirmed novel
coronavirus 2019 and fever/pneumonia
to Celebrex capsules 200mg / time
twice a day for 7 days or routine
treatment.
Piclidenoson NCT04333472 Israel Open label randomized trial. Duration of viral shedding in days [ Time Not yet recruiting; Low
N=40 hospitalised patients with COVID- Frame: 28 days ] Estimated Primary
(CF101) 19 randomised to Piclidenoson or Time to clinical recovery (TTCR) in days [ Completion: June 6,
Mechanism of action is standard of care Time Frame: 28 days ] 2020
A3AR mediated and Treatment-emergent adverse events
includes modulation of key (AEs) [ Time Frame: 28 days ]
signaling proteins, such as
PI3K, PKA, PKB/Akt, IKK
and NF-kB, resulting in de-
regulation of the Wnt/β-
catenin pathway and
inhibition of inflammatory
cytokine production
Glucocorticoids
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Hydrocortisone, Solu- NCT04348305 Denmark Randomised, double blinded, placebo Days alive without life support after 28 Recruiting High
Cortef Eudra CT: 2020-001395- controlled. days.
15 1000 participants with COVID-19 Estimated Primary
Licensed for: Acute treated with intravenous infusion of Completion: March
adrenal insufficiency (COVID STEROID) hydrocortisone 200 mg or placebo over 30, 2021
(Addisonian crisis), Status 24 hours.
asthmaticus and
Anaphylactic shock
98
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Ciclesonide NCT04377711 Not stated Phase 3, multicenter, randomized, Percentage of patients with subsequent Not yet recruiting High
double-blind, placebo-controlled study emergency department visit or hospital
Sponsor: to assess the safety and efficacy of admission for reasons attributable to Estimated Primary
Covis Pharma S.à.r.l. Ciclesonide metered-dose inhaler in COVID 19 by day 30 [ Time Frame: Day Completion Date:
non-hospitalized patients 12 years of 30 ] September 1, 2020
age and older with symptomatic COVID-
19 infection.
99
Version of 16.06.2020
N=210 subjects hospitalized with a
clinical diagnosis of COVID-19
pneumonia and
need of oxygen therapy.
Randomized to Prednisone (0.7
mg/kg/d) + standard of care or only
standard of care
Dexamethasone NCT04360876 United states, Single-center, Phase 2a, pragmatic, Ventilator Free Days (VFD) at Day 28 [ Not yet recruiting Medium
Colorado ??? randomized, double-blinded, placebo- Time Frame: 28 Days ]
Sponsor: controlled trial to determine the safety Estimated Primary
University of Colorado, and estimate efficacy of targeted Completion Date:
Denver corticosteroids in mechanically September 30, 2020
ventilated patients with the hyper-
inflammatory sub phenotype of ARDS
due to coronavirus disease 2019.
100
Version of 16.06.2020
N = 250, with Covid-19 infection, need Mortality Estimated Study
for ventilation and bilateral pulmonary Completion Date:
infiltrates [Time Frame: 14 days followup for April 30, 2020
every patient in each group]
Corticosteroid NCT04355247 Puerto Rico Phase II pilot exploratory study, single Clinical complete response criteria Recruiting; Low
group assignment. requires all the following:
Sponsor: N=20 COVID-19 regardless of severity Estimated Primary
Auxilio Mutuo Cancer will be assigned to Methylprednisolone No need for ventilatory support at any Completion: July 31,
Center 80 mg IV bolus injection will be given point 2020
daily x 5 O2 Saturation of >/= 93% by day 14 of
therapy
Alive by day 28 from registration
CT chest with minimal or no evidence of
disease by day 28 from registration
Dexamethasone NCT04327401 Brazil Open label randomised trial. Ventilator-free days [ Time Frame: 28 Not yet recruiting; Low
N=290 participants with days after randomization ] Estimated Primary
Moderate/severe ARDS randomised to Completion; August
dexamethasone or Standard treatment 30, 2020
Dexamethasone NCT04347980 France Single blind randomized clinical trial. Day-28 mortality [ Time Frame: 28 days Recruiting; Low
Reanimation N=122 with COVID-19 ARDS after randomization ] Estimated Primary
Sponsor: adulte. Hopital torandomised to Completion; June
Centre Chirurgical Marie Marie Dexamethasone+ Hydroxychloroquine, 2020
Lannelongue Lannelongue or Hydroxychloroquine
Corticoids Eudract: 2020-001307- Spain Open label randomized controlled trial. Death for any cause in the first 28 days Ongoing Low
16 N=104 Patients with ARDS secondary to after randomization.
COVID-19.
Test-drug: Solumedrol
Comparator not stated
Glucocorticoid NCT04244591 China, Beijing Phase 2 and 3: open label, randomised Lower Murray lung injury score (Time Completed; Low
controlled trial Frame: 7 days and 14 days after
randomization) Update: Completed as
N=80 with severe disease (ICU of April 15 2020
admission) randomised to
methylprednisolone 40 mg x2 for 5 days
Prednisone NCT04344288 France, multiple Phase 2, randomized, open-label trial. Number of patients with a theoretical Recruiting Medium
sites respiratory indication for transfer to
Sponsor: 2020-001553-48 N=304 patients hospitalized for Covid- intensive care unit evaluated by a SpO2 Estimated Primary
Hospices Civils de Lyon 19 viral pneumonia randomized to <90% stabilized at rest and under not Completion Date:
CORTI-Covid prednisone during 10 days (oral, 0.75 more than 5 L / min of supplemental November 2020
mg/kg/day during 5 days then 20 oxygen using medium concentration
mg/day during 5 more days) or nothing mask. [ Time Frame: 7 days ]
(control group).
Methylprednisolone NCT04263402 Tongji Hospital Phase 4 open label, Prospective, 1. Rate of disease remission Not yet recruiting; Low
Randomised Controlled Cohort Study 2. rate and time of entering the critical Estimated study
stage completion: July 1,
2020
101
Version of 16.06.2020
N=100 patients with severe pneumonia
randomised to <40 mg
methylprednisolone/day, or
40-80 mg/day
Methylprednisolone NCT04273321 China, Hubei Open label, randomised trial The incidence of treatment failure in 14 Recruiting; Low
days Estimated primary
N=400 patients completion: May 1,
Randomised to Methylprednisolone 2020
1mg/kg/day ivgtt for 7 days or ?
Methylprednisolone ChiCTR2000029386 Chongqing, a Randomised Controlled Trial Mortality 12 weeks, 4 weeks and clinical Recruiting Low
China improvement From 2020-01-29 to
http://www.chictr.org.c N=40 with severe covid-19 randomised 2021-01-29
n/showproj.aspx?proj=4 to methylprednisolone or conventional
8777 treatment
https://www.ncbi.nlm.ni
h.gov/pubmed/3214977
3
Tacrolimus + NCT04341038 Spain Phase 3, Open, randomized, single Time to reach clinical stability [ Time Recruiting Low
Methylprednisolone centre trial (the statistician who will Frame: 28 days ]
EudraCT Number: finally carry out the analyses will be Estimated Primary
Sponsor: Hospital 2020-001445-39 blind to the treatment received by the Completion Date: June
Universitari de Bellvitge patients). 1, 2020
TACRO-BELL-COVID
N=84 hospitalized severe COVID-19 lung
injury patients randomized to
Methylprednisolone + Tacrolimus or
usual care.
Corticosteroids ChiCTR2000029656 Hubei, China Open label randomised controlled trial. ECG, chest imaging, complications Not yet recruiting. Low
http://www.chictr.org.c N=100 patients with Covid-19
n/showproj.aspx?proj=4 randomised to From2020-02-14 To
9086 methylprednisolone or 2020-04-14
standard treatment
Corticosteroids ChiCTR2000030481 Hubei, China Parallel study, blinding unknown; The time of duration of COVID-19 Recruiting; Low
N=200 nucleic acid RT-PCR test results of
http://www.chictr.org.c corticosteroid therapy timing respiratory specimens (such as throat From2020-03-01 To
n/showproj.aspx?proj=5 early timing, swabs) or blood specimens change to 2020-04-30
0453 medium timing, or negative.
conventional treatment
Corticoids, inhaled 2020-001616-18 Spain Randomised, open label clinical trial. A composite outcome: patients Ongoing by Low
N=300 patients with COVID-19 requiring mechanical ventilation, high 28.04.2020.
Pulmicort Turbuhaler 400 randomised to budesonide or standard flow oxygenotherapy, receiving Estimated study
microgramos (budesonide) of care systemic corticoids and/or anti IL1 , anti duration: 6 months
IL-6 and/or dying for any cause
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Methylprednisolone NCT04323592 Italy Interventional study with historical Death or ICU admission or Invasive Recruiting; Low
matched controls. mechanical ventilation [ Time Frame: Estimated Primary
N=104 patients with COVID-19 28 days ] Completion: May,
treated with methylprednisolone or 2020
standard of care
Prednisone 2020-001622-64 Spain Randomised open label controlled trial. admission after 30 days Ongoing by Low
TAC-COVID19 N=200 Outpatients with COVID-19 28.04.2020.
randomised to prednisone or standard Estimated study
of care duration: 3 months
Inhaled Steroid + NCT04331054 Paris, France Randomised open label study. Time (in days) to clinical improvement Recruiting; Medium
formoterol fumarate N=436 hospitalised patients with covid- within 30 days after randomization Estimated Primary
(Symbicort) 19 randomised to symbicort or Completion: July 13
standard of care 2020
Budesonied NCT04355637 Spain Randomized, controlled open label Composite variable that includes the Not yet recruiting; Low
(inhaled) clinical trial. initiation of treatment with high flow- Estimated Primary
N=300 hospitalised patients with O2 therapy, non-invasive or invasive Completion: August
COVID-19 randomised to Inhaled ventilation, systemic steroids, use of 31, 2020
budesonide or standard treatment biologics (anti IL-6 or anti IL-1) and/or
death) at day 15 after initiation of
therapeutic intervention
Budesonide NCT04361474 France ??? Phase 3, multicenter, randomized, Patient with more than 2 points on the Not yet recruiting Medium
single-blinded trial to evaluate the ODORATEST [ Time Frame: 30 days ]
Sponsor: efficacy of local budesonide (nasal Percentage of patients with an Estimated Primary
Fondation irrigation) in the management of improvement of more than 2 points on Completion Date:
Ophtalmologique Adolphe persistent hyposmia in COVID-19 the ODORATEST score (5) after 30 days April 25, 2020
de Rothschild patients. of treatment
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Stem cell therapy NCT04288102 Hubei, China Phase 2 Prospective, double-blind, Improvement time of clinical critical Recruiting; High
multicentre, randomised trial treatment index within 28 days
Sponsor: Beijing 302 Estimated primary
Hospital N=60 severe Covid-19 patients Side effects in the MSCs treatment completion date:15
randomised 2:1 to group July 2020
3 intravenous doses of mesenchymal
stem cells (MSCs)
or placebo (saline).
Umbilical Cord-derived NCT04333368 France Double-blinded, randomised trial. Respiratory efficacy evaluated by the Estimated Primary High
Mesenchymal Stromal N=60 patients with ARDS randomised to increase in PaO2/FiO2 ratio from Completion; August
Cells MSC or placebo baseline to day 7 31, 2020
Sponsor: Assistance
Publique - Hôpitaux de
Paris
Allogenic human umbilical NCT04398303 Not stated Phase 1/2 trial of ACT-20 in patients Mortality at day 30 [ Time Frame: 30 Not yet recruiting Medium
derived mesenchymal with moderate to severe COVID-19 days post treatment ]
stem cells (ACT-20-MSC), AHS 20-03 pneumonia in two parts. Estimated Primary
Allogenic human umbilical Completion Date:
derived mesenchymal Part 1: open-label study, n=10 (5 with October 2020
stem cells in conditioned moderate COVID-19 pneumonia and 5
media (ACT-20-CM) with severe COVID-19 pneumonia).
Randomized 1:1 to ACT-20-CM or ACT-
Sponsor: 20-MSC resuspended in ACT-20-CM.
Aspire Health Science
Part 2: randomized, blinded, placebo-
controlled study. N=60 (30 with
moderate COVID-19 pneumonia and 30
with severe COVID-19 pneumonia).
Randomized 1:1:1 to ACT-20-MSC in
ACT-20-CM, ACT-20-CM or placebo.
Cord blood stem cells NCT04393415 Egypt Randomized, double-blinded trial to The number of patients with positive Not yet recruiting Medium
evaluate the Effect of Cord Blood in covid 19 who will improve after
Sponsor: Improving the Symptoms of Covid-19 receiving stem cells [ Time Frame: 2 Estimated Primary
Aljazeera Hospital weeks ] Completion Date: July
N=100 patients with positive covid-19, 25, 2020
symptoms and isolated in the hospital
randomized to cord blood stem cells or
placebo
BM-Allo.MSC NCT04397796 Not stated A phase 1b randomized, double-blind, 1.Incidence of AEs [ Time Frame: 30 Not yet recruiting Medium
placebo-controlled study of the safety days ]
Sponsor: NantKwest, Inc. of therapeutic treatment with 2.Mortality [ Time Frame: 30 days ] Estimated Primary
immunomodulatory mesenchymal stem 3.Death [ Time Frame: 30 days ] Completion Date: June
cells. 4.Number of ventilator-free days [ Time 2021
Frame: 60 days ]
N = 45 adults with COVID-19 infection
requiring mechanical ventilation
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Wharton Jelly NCT04390139 Spain A phase 1/2, double-blind, randomized, All-cause mortality at day 28 [ Time Recruiting Medium
mesenchymal stromal cells placebo-controlled pilot clinical trial for Frame: Day 28 ]
the evaluation of the efficacy and safety Estimated Primary
Sponsor: Banc de Sang i of two doses of WJ-MSC. Completion Date:
Teixits October 2020
N = 30 patients with moderate and
acute respiratory distress syndrome
secondary to infection by COVID-19
Wharton Jelly NCT04390152 Colombia A phase 1/2 double-blinded, placebo- Intergroup mortality difference with Not yet recruiting Medium
mesenchymal stromal cells controlled, randomized trial to evaluate treatment [ Time Frame: 28 days. ]
the safety and efficacy of intravenous Estimated Primary
Sponsor: BioXcellerator infusion of Wharton's Jelly Derived Completion Date:
Mesenchymal Stem Cell compared to November 2020
hydroxychloroquine, lopinavir/ritonavir
or azithromycin and placebo
N=10
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3. Clinical Respiratory Changes:
Respiratory rate per minute [ Time
Frame: Three weeks ]
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Version of 16.06.2020
evaluate the safety and efficacy of been achieved in less than 7 days after Estimated study
Sponsor: CITOSPIN S.L. allogeneic mesenchymal stem cells IMP administration. completion: Unknown
(MSV®-allo) Proportion of patients surviving on day
28 from diagnosis
N = 24 patients in acute respiratory
failure with COVID-19 pneumonia
Stem Cell Product NCT04341610 Denmark Phase 1/2, randomized and double- Changes in clinical critical treatment Not yet recruiting Medium
(allogeneic adipose- blind placebo-controlled study to index
derived mesenchymal 2020-001330-36 evaluate the impact of CSCC_ASCs on Estimated Primary
stromal cell) the activated immune system and Completion Date:
clinical efficacy on pulmonary function.. January 30, 2021
Sponsor: Rigshospitalet,
Denmark N=40 patients in respirator.
Allogeneic adipose-derived NCT04348435 United States, Phase 2, randomized, double-blind, 1. Incidence of hospitalization for Enrolling by invitation Medium
mesenchymal stem cells Texas placebo-controlled, single center trial COVID-19 [ Time Frame: week 0
(HB-adMSCs)) on the efficacy and safety of Allogeneic through week 26 (end of study) ] Estimated Primary
HB-adMSCs to provide immune support Completion Date:
Sponsor: against COVID-19. 2. Incidence of symptoms associated December 31, 2020
Hope Biosciences with COVID-19 [ Time Frame: week 0
N=100 subjects with high or very high through week 26 (end of study) ]
exposure risk of contracting COVID-19,
but no signs of COVID-19.
Randomized to HB-adMSCs 200MM or
HB-adMSCs 100MM or HB-adMSCs
50MM or placebo.
Adipose tissue-derived NCT04348461 Spain? Phase 2, randomized, blinded, 1.Efficacy of the administration of Not yet recruiting Medium
mesenchymal stromal cells controlled clinical trial to assess the allogeneic mesenchymal stem cells
safety and efficacy of intravenous derived from adipose tissue assessed by Estimated Primary
Sponsor: Instituto de administration of expanded allogeneic Survival Rate) Completion Date:
Investigación Sanitaria de adipose tissue adult mesenchymal September 15, 2020
la Fundación Jiménez Díaz stromal cells 2.Safety of the administration of
allogeneic mesenchymal stem cells
N = 100 critically ill patients with derived from adipose tissue assessed by
COVID-19 randomized to either control Adverse Event Rate
or treatment group.
Human Umbilical Cord NCT04293692 China, Hubei Triple blinded randomised controlled Size of lesion area by chest imaging Recruiting; Medium
Mesenchymal Stem Cells trial.
(UC-MSCs) therapy N=48 with moderate - severe covid19 Estimated primary
randomised to completion date/
Sponsors: UC-MSCs or Estimated study
Puren Hospital Affiliated to placebo completion:
Wuhan University of May 1 2020/Feb 1,
Science and Technology 2021
Human Mesenchymal ChiCTR2000030138 Hainan, China Phase 2; Randomised, double blind, Clinical index Not yet recruiting; Medium
Stem Cells placebo controlled trial From2020-02-24 To
2020-05-31
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Sponsor: Chinese PLA http://www.chictr.org.c N=60 randomised to human umbilical
General Hospital n/showproj.aspx?proj=5 cord mesenchymal stem cells (UC-MSC),
0004 or placebo
Mesenchymal stem cells NCT04339660 China, Hubei Randomised, double blinded, placebo- The immune function (TNF-α 、IL-1β、 Recruiting; Estimated Medium
Sponsor: controlled trial. IL-6、TGF-β、IL-8、PCT、CRP) [ Time Primary Completion:
Puren Hospital Affiliated to N=30 patients with COVID-19 Frame: Observe the immune function of June 30, 2020
Wuhan University of randomised to mesenchymal stem cells the participants within 4 weeks ]
Science and Technology or placebo
Blood oxygen saturation [ Time Frame:
Monitor blood oxygen saturation of the
participants within 4 weeks ]
WJ-MSC 2020-001505-22 Spain Phase 1/2, Double-blind, randomized, All-cause mortality at day 28 Ongoing Medium
parallel, placebo-controlled pilot clinical
Sponsor: Banc de Sang i trial, nested in a prospective cohort Estimated duration of
Teixits observational study, for the evaluation the trial: 6 months
of the efficacy and safety of two doses
of WJ-MSC in patients with acute
respiratory distress syndrome
secondary to infection by COVID-19.
MultiStem NCT04367077 United States, Open-label lead-in followed by a double 1. Ventilator-Free Days [ Time Frame: Recruiting Medium
Ohio (multiple blinded, randomized, placebo- Day 0 through Day 28. ]
Sponsor: MACoVIA sites) controlled phase 2/3 trial to evaluate Estimated Study
Athersys, Inc the safety and efficacy of MultiStem® 2. Safety and Tolerability as measured Completion Date:
therapy in subjects with acute by the incidence of treatment- August 2022
respiratory distress syndrome (ARDS) emergent adverse events as assessed
due to COVID-19. by CTCAE v5.0. [ Time Frame: Day 28 ]
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The first 10 consecutive patients will all
receive investigational product. 2. Safety of the Investigational Product.
If there are no safety concerns, the trial Incidence of later reactions attributed
will proceed with enrollment on the to the investigational product as
phase 2 portion of the study where the measured by any one of the following:
subsequent 20 patients will be rash, infection, allergic reaction, or any
randomized in a 1:1 fashion between other symptoms associated with
treatment with MSCs and standard of infusion of the investigational product.
care. [ Time Frame: 28 days ]
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Group 2: patients in a ventilator: saline
injections
Group 3: patients in a ventilator: MSC
injections
Cymerus mesenchymal Early news Australia Phase 2 Primary endpoints will be improvement Study approved start Low
stem cells https://www.clinicaltrial at sites in New the open-label, randomised in PaO2/FiO2 ratio by day 7, along with May 2020
sarena.com/news/cynat South Wales in 1:1 controlled trial will assess early safety and tolerability up to day 28
a-therapeutics-covid-19- alliance with efficacy of Cymerus mesenchymal stem Estimated primary
Sponsor: trial/ the Cerebral cells to treat adult Covid-19 patients completion not known
Australia-based Cynata Palsy Alliance admitted to intensive care
Therapeutics Research
Institute and N=24 adults admitted to intensive care
the Covid-19 due to Covid-19
Stem Cell
Treatment Twelve patients will be given Cymerus
(CSCT) Group MSC infusions
investigators
Mesenchymal Stem Cells NCT04377334 Germany Phase 2, randomized, open-label study Lung injury score [ Time Frame: day 10 ] Not yet recruiting Low
(MSCs) to evaluate the safety, toxicity and
RESCOVID immunological effects of infusion of Estimated Primary
Sponsor: MSCs and whether this therapy has an Completion Date:
University Hospital influence on the resolution processes in November 2020
Tuebingen ARDS patients infected with Severe
acute respiratory syndrome coronavirus
2 (SARS-CoV-2).
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Allogeneic mesenchymal EudraCT number: 2020- Spain A phase 2, randomized, open-label Mortality due to lung involvement due Ongoing Low
cells 001450-22 clinical trial to explore the efficacy of to SARS-CoV-2 virus infection at 28 days
allogeneic mesenchymal cells from of treatment Estimated Primary
Sponsor: Fundación de umbilical cord tissue compared to Completion Date:
Investigación del Hospital standard of care. November 5, 2021
Infantil Universitario Niño
Jesús N = 106 patients with severe
pulmonary involvement by COVID-19.
Mesenchymal Stem Cells NCT04366323 Not stated Phase I/II, randomized, controlled, 1. Safety of the administration of Not yet recruiting Low
open-label trial to assess the safety and allogeneic mesenchymal stem cells
Sponsor: Andalusian efficacy of intravenous administration derived from adipose tissue assessed by Estimated Study
Network for Design and of Allogeneic Adult Mesenchymal Stem Adverse Event Rate [ Time Frame: 12 Completion Date:
Translation of Advanced Cells of expanded adipose tissue in months ] October 2021
Therapies patients with severe pneumonia due to
COVID-19. 2. Efficacy of the administration of
allogeneic mesenchymal stem cells
N=26 randomized to Mesenchymal derived from adipose tissue assessed by
Stem Cells or standard of care. Survival Rate [ Time Frame: 28 days ]
Mesenchymal Stem Cells NCT04371601 China, Fujian Early Phase 1, randomized, open-label Changes of oxygenation index Active, not recruiting Low
(MSCs) to evaluate to the safety and (PaO2/FiO2) ,blood gas test [ Time
effectiveness of MSCs in the treatment Frame: 12 months ] Estimated Study
Sponsor: of pneumonia of covid-19. Completion Date:
Fuzhou General Hospital December 31, 2022
N=60 patients with severe COVID-19
pneumonia randomized to MSCs +
conventional symptomatic treatments
(such as antiviral (oseltamivir),
hormones, oxygen therapy, mechanical
ventilation and other supportive
therapies) or conventional symptomatic
treatments only.
Mesenchymal cells NCT04366271 Spain A phase 2, randomized, open-label Mortality due to lung involvement due Not yet recruiting Low
controlled to explore the efficacy of to SARS-CoV-2 virus infection at 28 days
Sponsor: Hospital Infantil allogeneic mesenchymal cells from of treatment [ Time Frame: 28 days ] Estimated Primary
Universitario Niño Jesús, umbilical cord tissue compared to Completion Date: July
Madrid, Spain Standard of care. 31 2020
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Sponsor: Quovadis the treatment of ARDS in COVID-19 Estimated Primary
Associazione patients. Completion Date: 06-
06-2020
N = 60 patients are allocated randomly
to three groups 1:1:1:
Control. Conventional therapy for virus
treatment and supportive care for ARDS
Intervention Group 1. Patients will
receive two doses of MSCs
Intervention Group 2. Patients will
receive two doses of MSCs plus two
doses of extracellular vesicles (EVs)
Allogenic Adipose Tissue- 2020-001364-29 Spain (multiple Phase I/II, randomized, controlled, Safety endpoints: Ongoing Low
Derived Mesenchymal sites) open-label clinical trial to evaluate the Incidence of Adverse Events and Serious
safety and efficacy of Allogenic Adipose Adverse Events, related to the Duration: 1 year and 3
Sponsor: Tissue-Derived Mesenchymal Stem Cells investigational drug or the month
Red Andaluza de Diseño y Expanded in patients with severe administration procedure, graduated
Traslación de Terapias COVID-19 pneumonia according to the common toxicity
Avanzadas-Fundación criteria scale (CTCAE) [12 months post-
Progreso y Salud N=26 randomized to Allogenic Adipose infusion].
Tissue-Derived Mesenchymal (conc.
number 80000000 to 160000000) or Efficacy endpoints:
treatment according to clinical practice - Reduction of the SARS-CoV-2 viral load
by covid-19 (Hydroxychloroquine + by PCR on days 6 and 15.
Azithromycin or Lopinavir / ritonavir) or - Mortality at day 15 and 28
Allogenic Adipose Tissue-Derived - Proportion of patients in categories 5,
Mesenchymal expanded (conc. number 6 or 7 of the ordinal scale of 7 points on
160000000 to 320000000) days 15 and 28 days
- Proportion of patients needing rescue
therapy (Tocilizumab, corticosteroids,
or therapies under investigation in
clinical trials)
- Time to get an improvement in a
category since admission to the ordinal
scale.
Mesenchymal Stromal NCT04361942 Spain Phase 2, double-blind, randomized trial 1. Proportion of patients who have Recruiting Low
Cells to evaluate safety and efficacy of achieved withdrawal of invasive
allogenic mesenchymal stromal cells for mechanical ventilation [ Time Frame: 0- Estimated Primary
Sponsor: treatment of acute respiratory failure in 7 days ] Completion Date:
Red de Terapia Celular patients with COVID-19 pneumonia. November 30, 2020
2. Rate of mortality [ Time Frame: 28
N=24 adult subjects with severe COVID- days ]
19 pneumonia randomized to
intravenous injection of 1 million MSV
cells/Kg in 100 ml of saline or placebo.
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Umbilical Cord NCT04355728 United States, Randomised open label study. Incidence of pre-specified infusion Recruiting; Low
Mesenchymal Stem Cells Florida N=24 intubated patients with COVID-19 associated adverse events [ Time Estimated Primary
randomised to Umbilical Cord Frame: Day 5 ] Completion Date:
Mesenchymal Stem Cells or standard of Incidence of Severe Adverse Events [ December 31, 2020
care Time Frame: 90 days ]
Human umbilical cord ChiCTR2000031430 China, Hubei, Phase 2, prospective, open, non- Several outcomes are mentioned as Recruiting Low
mesenchymal stem cells Wuhan randomized, parallel, 1:1 controlled primary outcomes.
(multicenter) clinical trial to evaluate the safety and From 2020-03-14 To
Sponsor: The Fifth Medical efficacy for human umbilical cord 2021-12-31
Center of PLA General mesenchymal stem cells in COVID-19
Hospital, China, Beijing induced pulmonary fibrosis.
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N=56 participants are either over 50 Incidence of symptoms for COVID-19 [
years of age, have preexisting Time Frame: week 0 through week 26
conditions, or are at high exposure risk (end of study) ]
of contracting COVID-19 will receive
stem cell therapy
Human NK cells and MSCs ChiCTR2000030944 Jiangxi, China An open, multi-center, control, Changes of serum inflammatory factors, Not yet recruiting; Low
transplantation exploratory clinical study mortality and safety outcomes Estimated duration:
N=20 patients with COVID-19 From 2020-03-01 To
randomised to human NK cells and 2020-08-31
MSCs transplantation or standard of
care.
Mesenchymal Stem Cell EudraCT: Spain Open label, randomized, controlled Several primary end-points are Ongoing buy Low
2020-001266-11 clinical trial with two treatment arms to mentioned. Among others, survival at 28.04.2020
evaluate the safety and efficacy of 28 days after treatment Estimated duration: 8
intravenous administration of expanded months
allogeneic adipose tissue adult
mesenchymal cells in critically ill
patients COVID-19.
N=100 intubated patients with COVID-
19
Bone Marrow-Derived NCT04346368 China, A randomized, single-blinded, phase Changes of oxygenation index Not yet recruiting Low
Mesenchymal Stem Cell Guangdong 1/2 controlled study. (PaO2/FiO2)
(BM-MSCs) Estimated Study
N = 20 severe patients with COVID-19 Side effects in the BM-MSCs treatment Completion Date:
Sponsor: Guangzhou receiving BM-MSCs or placebo. group December 2020
Institute of Respiratory
Disease
Mesenchymal stem cells ChiCTR2000030866 China, Hu’nan, Open-label, single-arm, observational - Oxygenation index (arterial oxygen Recruiting Low
(MSC) Changsha study. partial pressure (PaO2) / oxygen
concentration (FiO2)) [Time frame: 0 Study execute time:
Sponsor: Intravenous infusion of MSC based on hour, 24 hours, 3 days, 6 days, 10 days, 2020-02-01 to 2020-
The First Hospital of conventional treatments. 14 days, 28 days, random /14 days after 12-31
Changsha, China, Hu’nan discharge, random /28 days after
N=30 patients diagnosed as severe or discharge, 3 months, 6 months, 12
critical COVID-19 or patients who have months]
turned negative for viral nucleic acid - Conversion rate from serious to critical
detection but still have severe or critical patients, Conversion rate and
manifestations conversion time from critical to serious
patients and mortality in serious and
critical patients [Time frame: day 28]
Mesenchymal stem cells ChiCTR2000030835 China, He’nan Open label, non-randomised, clinical Primary outcome not stated. Recruiting Low
(MSC) trial
114
Version of 16.06.2020
The First Affiliated Hospital Low-dose group: 1 × 106 MSC/kg (n =
of Xinxiang Medical 10)
University, China, He’nan High-dose group: 2 × 106 MSC/kg (n =
10).
Mesenchymal Stromal NCT04345601 United States, Phase 1 open label single arm clinical Incidence of unexpected adverse events Not yet recruiting Low
Cells Texas trial to see if MSCs can help to treat within 28 days following infusion of Estimated study
respiratory infections caused by SARS- MSCs completion: February
Sponsor: Baylor College of CoV-2. 2022
Medicine
N = 30 age > 18 patients PCR confirmed
SARS-CoV-2 and mild or moderate to
severe acute respiratory distress
syndrome (ARDS) to be given the cell
product by intravenous injection (into
the vein through an IV line). Dose:1 x
10^8 MSCs.
Allogeneic http://investorsmedia.m USA, eventually Placebo-controlled phase 2/3 study. Not clearly stated. Not yet recruiting; Low
Mesenchymal stemcells esoblast.com/static- also Europa and Multicentre study Overall survival and ARDS parameters
Product: files/e63bf0d5-7dd5- China Planned number of patients: 340
Mesoblast holds an 46c0-8381- Placebo-kontrol-leret Fase2/3.
Investigatio-nal New Drug c2e24bacb130
(IND) App from FDA for Press release of planned
use in the treatment of study:
patients with COVID-19 Remestemcel-L is
ARDS developed for various
inflammatory
conditions, by down-
regulating the
production of pro-
inflamma-tory
cytokines. Safety
andefficacy of
remestemcel-L iv
infusions have been eva-
luated in over 1,100
patients, eg successful in
a Phase 3 trial for
steroid-refractory acute
graft versus host disease
(aGVHD) a condi-tion
similar to the cytokine
storm process as is seen
in COVID-19 ARDS.
Stem cells NCT04331613 Beijing, China Phase 1/2 clinical study. Single arm Adverse reaction (AE) and severe Recruiting; Low
study. adverse reaction (SAE);
N=9 with COVID-19 Changes of lung imaging examinations
115
Version of 16.06.2020
Human Embryonic Stem Dose escalation study with 3 cohort Estimated Primary
Cells Derived M Cells with 3 patients in each cohort. Completion:
(CAStem) December 2020
Stem cell therapy NCT04252118 China Phase 1 Open label, non-randomised Size of lesion area by chest radiograph Recruiting; Low
intervention study or CT (time frame day 28)
Side effects day (time frame day 180) Estimated primary
N=20 patients with covid19 completion date/
Treatment: Estimated study
N=10 treated with MSN completion:
N=10 treated with conventional Dec 2020/December,
treatment 2021
Stem cell therapy; NCT04276987 China Phase 1, open label pilot study Adverse reactions Not yet recruiting; Low
Time to clinical improvement (28 days)
Allogenic Adipose N=30 with severe covid19, Estimated primary
Mesenchymal Stem Cells Single group assignment completion: May 31,
2020
Stem cell therapy; NCT04273646 China, Hubei Open label, randomised study Pneumonia severity index week 0-week Not yet recruiting; Low
Umbilical cord N=48 with severe covid19; 12.
mesenchymal stem cells. Randomised to stem cell therapy or Oxygenation index Estimated primary
Sponsor: Wuhan Union placebo completion:
Hospital, China June 30 2020
umbilical cord ChiCTR2000029569 China, Hubei Open label PSI Not recruiting Low
mesenchymal stem cell N=30 with severe and critical covid-19
http://www.chictr.org.c randomised to From2020-02-05 To
n/showproj.aspx?proj=4 Stem cell or conventional treatment 2021-04-30
9062
umbilical cord blood ChiCTR2000029572 China, Hubei Open label PSI Not recruiting Low
mononuclear cells http://www.chictr.org.c N=30 with severe covid 19 randomised
n/showproj.aspx?proj=4 to From2020-02-05 To
1760 Stem cell or conventional treatment 2021-04-30
Stem cell therapy; NCT04269525 China, Hubei Phase 2, open label Oxygenation index day 14 Recruiting; Low
Umbilical cord- derived Estimated primary
mesenchymal stem cells N=10, serious or critical covid19 completion:
Sponsor: ZhiYong Peng April 30, 2020
Human Menstrual Blood- ChiCTR2000029606 Zhejiang, China Open label, 5 arm study. Mortality Recruiting; Low
Derived Stem Cells http://www.chictr.org.c Critically ill patients treated with
n/showproj.aspx?proj=4 stem cells, From2020-01-15 To
9146 conventional treatment, 2022-12-31
artificial liver therapy,
artificial liver therapy + stem cells, or
Conventional treatment
Umbilical cord ChiCTR2000029812 Guangdong, Open label, Not recruiting ; Low
mononuclear cells China N= 60 patients with Covid 19 Time to disease recovery
http://www.chictr.org.c randomised to umbilical cord blood From2020-02-20 To
n/showproj.aspx?proj=4 mononuclear cells or conventional 2021-02-20
9374 treatment
116
Version of 16.06.2020
Cord Blood Mesenchymal ChiCTR2000029816 Guangdong, Open label, Time to disease recovery; Not recruiting ; Low
Stem Cells http://www.chictr.org.c China N= 60 patients with Covid 19
n/showproj.aspx?proj=4 randomised to Cord Blood From2020-02-20 To
9389 Mesenchymal Stem Cells or 2021-02-20
conventional treatment
Cord Blood NK Cells ChiCTR2000029817 Guangdong, Open label, Time to disease recovery; Not recruiting ; Low
Combined with Cord Blood http: china N= 60 patients with Covid 19
Mesenchymal Stem Cells //www.chictr.org.cn/sho randomised to From2020-02-20 To
wproj.aspx?proj=49384 High dose NK cells, and mesenchymal 2021-02-20
stem cells,
Conventional dose NK cells and
mesenchymal stem cells, or
Preventive dose NK cells and
mesenchymal stem cells.
Cord Blood NK Cells ChiCTR2000029818 Guangdong, Open label, Time to disease recovery; Not recruiting ; Low
Combined with Cord Blood http: china N= 60 patients with Covid 19
Mesenchymal Stem Cells //www.chictr.org.cn/sho randomised to From2020-02-20 To
wproj.aspx?proj=49382 High dose NK cells, and mesenchymal 2021-02-20
stem cells,
Conventional dose NK cells and
mesenchymal stem cells, or
Preventive dose NK cells and
mesenchymal stem cells.
mesenchymal stem cells ChiCTR2000029990 Beijing, Hubei, Phase 1-2; Improved respiratory system function Recruiting; Low
http://www.chictr.org.c Shanghai N=120, Severe covid-19 randomised to (blood oxygen saturation) recovery From2020-01-30 To
n/showproj.aspx?proj=4 mesenchymal stem cells or saline time; 2020-03-31
9674
Umbilical cord Wharton's ChiCTR2000030088 Beijing, China Type of study not stated. Blinding not The nucleic acid of the novel Not yet recruiting; Low
Jelly derived mesenchymal stated coronavirus is negative From2020-03-01 To
stem cells http://www.chictr.org.c N= 40 with critical covid-19 CT scan of ground glass shadow 2021-12-31
n/showproj.aspx?proj=4 Treatment: stem cells (n=20) disappeared
9902 40 ml saline (n=20)
Wharton's Jelly NCT04313322 Jordan Phase 1, single arm study Improvement of clinical symptoms; Recruiting. Low
Mesenchymal stem cells N=5 with COVID-19 Adverse events;
Sponsor: Stem Cells Arabia Viral RNA Estimated study
completion: Sept,
2020
Human umbilical cord ChiCTR2000030116; Jiangxi, China N=16 with critical covid-19; Time to leave ventilator on day 28 after Recruiting; Low
mesenchymal stem cells http://www.chictr.org.c Different stem cell doses receiving MSCs infusion From2020-02-01 To
n/showproj.aspx?proj=4 2020-08-31
9901
Mesenchymal stem cells ChiCTR2000030224 Hubei, China Clinical study, open label Several primary endpoints – not Not yet recruiting; Low
http://www.chictr.org.c specified
n/showproj.aspx?proj=4 Severe or critical covid-19 patients; From2020-02-14 To
9968 N=32 stratified severity and randomised 2020-05-31
to stem cells or injection with saline
117
Version of 16.06.2020
Umbilical cord ChiCTR2000030300 Jiangsu, China A single-centre, single arm, prospective, Time to disease recovery; Recruiting; Low
mesenchymal stem cells http://www.chictr.org.c open clinical study Exacerbation (transfer to RICU) time From2020-02-19 To
n/showproj.aspx?proj=5 N=9 2021-02-20
0022
Stem cell educator therapy NCT04299152 ? This is a prospective, two-arm, partially Number of Covid-19 patients who were Not yet recruiting; Low
masked, single center clinical study . unable to complete SCE Therapy [ Time Estimated study
N=20 patients with SARS-CoV-2 Frame: 4 weeks ] completion: Nov 2020
undergoing either stem cell therapy or
conventional treatment
Dental pulp mesenchymal NCT04302519 ? Early phase 1, single arm study Disappear time of ground-glass shadow Not yet recruiting, Low
stem cells N=24 patients with severe covid-19 in the lungs [Time Frame: 14 days] Estimated study
assigned to stem cell therapy completion: July 2021
Dental pulp mesenchymal NCT04336254 Renmin Single-center, Prospective, Randomised Time to Clinical Improvement Recruiting; Estimated Low
stem cells Hospital of Clinical Trial Primary Completion:
Wuhan N=20 patients with COVID-19 December 31, 2020
University, randomised to stem cells or placebo
China
NestCell® Mesenchymal NCT04315987 Not stated Phase 1 /2 study Disappear time of ground-glass shadow Not yet recruiting. Low
Stem Cell N=24 patients in the lungs
Sponsor: Azidus Brasil Estimated study
completion: June,
2020
Cardiovascular drugs
Angiotensin receptor blocker or ACE inhibitor
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Losartan NCT04312009 Minneapolis, Randomized Controlled Trial, double Sequential Organ Failure Assessment Not yet recruiting High
Sponsor: University of Minnesota, blinded. (SOFA) Respiratory Score [ Time Frame:
Minnesota United States N=200 hospitalised patients with 28 days ] Estimated study
COVID-19 randomised to Losartan 25 completion. April 1,
mg daily or 2021
Losartan NCT04311177 Minneapolis, Randomized Controlled Trial, double Hospital Admission [ Time Frame: 28 Not yet recruiting High
Sponsor: University of Minnesota, blinded. days ]
Minnesota United States N=516 patients with COVID-19 not Estimated study
requiring hospitalisation randomised to completion. April 1,
Losartan 25 mg daily or placebo 2021
ACE inhibitor, angiotensin NCT04330300 Ireland Randomised open label study. Number of Covid-19 positive Not yet recruiting; High
receptor blocker, calcium N= 2414 Patients with hypertension participants who die, require intubation Estimated Primary
channel blocker, thiazide treated with ACE-inhibitor or ARB and in ICU, or require hospitalization for Completion: January
who are COVID-19 naïve randomised to non-invasive ventilation (NIV) [ Time 31, 2021
continue with ACEi /ARB, or Frame: 12 months ]
Change to thiazide or CCB
118
Version of 16.06.2020
Valsartan NCT04335786 Netherlands A Double-blind, Placebo-controlled first occurrence of intensive care unit Recruiting; High
Randomized Clinical Trial admission, mechanical ventilation or Estimated Primary
PRAETORIAN-COVID N=651 patients hospitalised with death [ Time Frame: within 14 days] Completion: July 2020
COVID-19 randomised to valsartan or
placebo
Ramipril NCT04366050 Not stated A phase 2, randomized, double-blind, Composite of mortality or need for ICU Not yet recruiting High
placebo-controlled trial to evaluate the admission or ventilator use [ Time
Sponsor: University of efficacy of ramipril to prevent ICU Frame: 14 days ] Estimated Study
California, San Diego admission, need for mechanical Number of patients with increased Completion Date:
ventilation or death in persons with disease severity [Time Frame: From April 2021
COVID-19 baseline to Day 3, Day 7, Day 14, Day
21, Day 28 or at any time during the
N = 560 study till 28 days post first dosing.]
Phase 3, double-blinded, placebo-
controlled, randomized trial on the
efficacy of Mycobacterium w + standard
care
119
Version of 16.06.2020
Medical University N=208 subjects in chronic (≥ 1 month) mechanical ventilation, or all-cause
Innsbruck ACEI/ARB therapy for treatment of death [ Time Frame: 30 days ]
arterial hypertension, diabetes mellitus,
heart failure or coronary artery disease
and proven and symptomatic SARS-
CoV2 infection ≤ 5 days.
Randomized to stopping/replacing
ACEI/ARB or no intervention (which
means further treatment with ACEI or
ARB).
ACEi / ARB NCT04338009 Not stated Open label randomised controlled trial. Hierarchical composite endpoint [ Time Not yet recruiting; Medium
Sponsor: N=152 patients with COVID-19 treated Frame: Up to 28 days ] Estimated Primary
University of Pennsylvania with ACEI or ARB as an outpatient prior The primary endpoint of the trial will be Completion:
to hospital admission. a global rank score that ranks patient December 31, 2020
Patients are randomised to outcomes according to four factors: (1)
continuation or discontinuation with time to death, (2) the number of days
ACEi or ARB supported by invasive mechanical
ventilation or extracorporeal
membrane oxygenation (ECMO), (3) the
number of days supported by renal
replacement therapy or
pressor/inotropic therapy, and (4) a
modified sequential Organ Failure
Assessment (SOFA) score.
ACEi/ARB discontinuation NCT04329195 France Randomised open label study. Time to clinical improvement from day Recruiting; Medium
N=554 patients treated with ACEi or 0 to day 28 Estimated primary
ARB randomised to discontinuation or completion:
continuation with RAS blocker May 9, 2020
ARB or ACE inhibitor NCT04318418 IRCCS Observational case control study Severe COVID-19 Estimated Primary Medium
Neuromed, N=5000 Completion: April
Sponsor: Neuromed IRCCS Department of 2020
Epidemiology
and Prevention,
Pozzilli, Italy
ARB/ACEi ChiCTR2000030453 Zhejiang, China Single arm study ratio of severe cases Not yet recruiting; Low
http://www.chictr.org.c N=100 treated with angiotensin
n/showproj.aspx?proj=5 receptor blocker /angiotensin No estimated end-
0381 converting enzyme inhibitor date
Angiotensin Receptor NCT04340557 Several Sharp Open label, randomised, controlled Mechanical ventilation [ Time Frame: Recruiting; Low
Blockers hospitals, trial. from date of patient admission to date Estimated Primary
California, N=200 patients with mild to moderate of patient discharge or date of death, Completion: October
Sponsor: Sharp HealthCare United States COVID-19 randomised to losartan or whichever came first, assessed up to 45 6, 2020
standard treatment days ]
ACE inhibitor NCT04345406 Egypt Open label randomized controlled trial number of patients with virological cure Not yet recruiting; Low
[ Time Frame: 6 months ]
120
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N=60 patients with COVID-19 Estimated Primary
randomised to ACI or conventional Completion:
treatment December 1, 2029?
Influenza vaccine, ACE NCT04367883 Spain Observational study of Influenza Hospital output and legth of ICU Recruiting Low
inhibitors (ACEI) and Vaccination (in patients who were admission [Time Frame: from March 1,
Angiotensin Receptor vaccinated previously) and treatment 2020] Estimated primary
Blocker (ARB) with ACEI and ARB in the evolution of Completion Date: July
Covid-19 infection 30, 2020
Sponsor: Consorci Sanitari
de Terrassa N = 2574, all ages, all hospital incomes
admitted to Hospital of Terrassa from
March 1, 2020
121
Version of 16.06.2020
Sponsor: D'Or Institute for the length of hospital stay and on the
Research and Education mortality of patients with SARS-CoV2
infection
Other
Product Study identifier Study location Study design Primary outcome Status of trial Importance
NCT04345887 Turkey, Istanbul Phase 4, triple-blinded, randomized p/f ratio [ Time Frame: 5 days ] Not yet recruiting Medium
Spironolactone trial to evaluate the effects of improvement in oxygenation
commonly used diuretic, Estimated Primary
Sponsor: spironolactone, on oxygenation in Completion Date: July
Istanbul University- covid-19 ARDS patients. 21, 2020
Cerrahpasa
N=60 randomized to Spironolactone
(2x100mg for 5 days) or placebo.
NCT04351763 Poland A phase 2/3, randomized, single- Clinical improvement [ Time Frame: Recruiting Medium
Amiodarone and blinded study investigate amiodarone Randomization to day 15 ]
Verapamil (ReCOVery-SIRIO) or verapamil compared with usual care. Estimated Study
Completion Date: April
N = 804 symptomatic patients 10, 2021
Sponsor: Nicolaus
hospitalized with confirmed COVID-19
Copernicus University
infection.
3 arms: experimental (amiodarone),
experimental (verapamil) and no
intervention (usual care)
NCT04365257 United States, A phase 2, randomized, open-label trial 1.Death Not yet recruiting Medium
Prazosin Maryland to assess the efficacy and safety of 2.Hospitalized, requiring mechanical
prazosin to prevent cytokine storm ventilation and/or high flow nasal Estimated Study
Sponsor: Johns Hopkins syndrome and severe complications. cannula and/or ICU/CCU admission (or Completion Date:
University equivalent) and/or ECMO December 2020
N = 220 hospitalized positive SARS-CoV- 3.Hospitalized, requiring supplemental
2 patients randomized in a 1:1 ratio to oxygen, not requiring ICU/CCU level
122
Version of 16.06.2020
receive either prazosin or standard of care (or interventions listed under
care. Outcome 2)
4.Cumulative incidence of grade 3 and 4
adverse events
5.Number of participants with serious
adverse events
6.Incidence of symptomatic
hypotension or hypotension requiring
cessation of prazosin
NCT04382924 Canada Phase 2/3, open-label, controlled, Patient clinical status (on the WHO 7- Not yet recruiting medium
Ifenprodil randomized trial on the efficacy of NP- point ordinal scale) at day 15 in IP
(NP-120) 120 (Ifenprodil) for hospitalized versus SOC control group patients: Estimated primary
patients with Covid-19 [Time Frame: Day 15] Completion: January
Sponsor: Algernon 2020
Pharmaceuticals N = 462, hospitalized with confirmed
Covid-19 infection requiring
supplemental oxygen randomized to
Ifenprodil + standard care or standard
care alone
Ifenprodil Early news South Korea Phase 2b/3 Study An improvement in the ordinal clinical Not stated Low
NP-120 (Ifenprodil) is an N- http://thestocksmarket. 100 patients with moderate/severe scale
methyl-D-aspartate net/2020/04/22/algerno disease, will be randomized in a 1:1
(NMDA) receptor n-submits-application- fashion to receive either standard of
antagonist specifically to-health-canada-for- care (SOC) or SOC and Ifenprodil (20 mg
targeting the NMDA-type ifenprodil-covid-19- three times per day) for a two-week
subunit 2B (Glu2NB). phase-2b-3- treatment period.
Ifenprodil prevents multinational-clinical-
glutamate signalling. The trial/
NMDA receptor is found
on many tissues including https://pennystocks.co
lung cells and T-cells, m/penny-stock-
neutrophils. news/2020/04/23/alger
non-receives-regulatory-
The Company believes NP- and-ethics-approval-for-
120 can reduce the phase-2-ifenprodil-
infiltration of neutrophils covid-19-human-study-
and T-cells into the lungs in-south-korea/
where they can release
glutamate and cytokines
respectively.
Sponsor: Algernon
Pharmaceuticals Inc
123
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NCT04380402 Not stated A phase 2 randomized open-label trial Deterioration in clinical status [ Time Not yet recruiting Low
Atorvastatin to assess whether adjunctive therapy of Frame: 30 days ]
COVID-19 infection with atorvastatin Estimated Primary
Sponsor: Mount Auburn reduces the deterioration in Completion Date:
Hospital hospitalized patients and improves December 31, 2021
clinical outcome compared to standard
care
N = 300
N = 1080. 3 arms:
No Intervention: Observation
Experimental: Aspirin
Experimental: Aspirin + vitamin D
Aspirin NCT04365309 China, Shaanxi Phas 2/3, randomized, open-label trial Clinical recovery time (TTCR) [ Time Enrolling by invitation Medium
to evaluate the protective effect of Frame: not more than 14 days ]
Sponsor: Aspirin in covid-19 patients. Estimated Study
Xijing Hospital Completion Date:
N=128 subjects with common and April 2020
severe covid-19 pneumonia randomized
to standard treatment or aspirin (100
mg/d, oral) + standard treatment.
124
Version of 16.06.2020
Defibrotide NCT04335201 Italy Phase 2 Primary endpoint: Not yet recruiting; Low
Prospective, interventional, single-arm, To demonstrate that the treatment Estimated Primary
Sponsor:
multicentric, open label trial with a with Defibrotide administered Completion:
IRCCS San Raffaele
parallel retrospective collection of data intravenously in addition to the best September 30, 2020
Prof. Ciceri Fabio
on not treated patients with Defibrotide available therapy according to
Use of Defibrotide to Reduce institutional guidelines is able to reduce
Progression of Acute Respiratory Failure the progression of acute respiratory
Rate in Patients With COVID-19 failure, the need of mechanical
Pneumonia ventilation, the transfer to the intensive
care unit or death, in patients with
N= 50 patients in the single arm with severe COVID-19 pneumonia.
documented COVID-19 pneumonia and
onset of pneumonia <14 days
Defibrotide NCT04348383 Spain A phase IIb, multi-center, randomized, Mortality rate [ Time Frame: : up to 30 Recruiting Medium
double-blinded, placebo controlled trial days ]
Sponsor: Fundacion para la (DEFACOVID) to evaluate defibrotide intravenous Estimated primary
Formacion e Investigacion infusion in the prevention and Completion Date: July
Sanitarias de la Region de treatment of COVID-19 respiratory 8, 2020
Murcia distress and cytokine release syndrome.
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Sponsor: Assistance N = 808 participants. Group 2: Ventilator free survival [ Time Estimated primary
Publique - Hôpitaux de 2 parallels arms, 1:1, stratified on Frame: day 28 ] Completion Date : July
Paris disease severity. 31, 2020
Group 1 : patients not requiring ICU
Group 2 : Respiratory failure AND
requiring mechanical ventilation
Anticoagulation NCT04359277 United States, A phase 3, randomized open label trial 1.All-cause mortality Recruiting Medium
New York to compare effectiveness of two dosing 2.Incidence of Cardiac Arrest
regimens currently used for prevention 3.Incidence of symptomatic Deep Estimated Study
Sponsor: NYU Langone of clotting events in COVID-19 positive Venous Thrombosis Completion Date:
Health inpatients 4.Incidence of Pulmonary Embolism April 16, 2021
5.Incidence of Arterial
N = 1000 hospitalized COVID-19 positive thromboembolism
patients with a D-dimer >500 ng/ml. 6.Incidence of myocardial infarction
Patients will be randomized to higher- 7.Incidence of hemodynamic shock
dose anticoagulation versus lower-dose
(e.g. prophylactic-dose) anticoagulation
in 1:1 ratio.
2020-001659-42 Spain Randomised, open label, clinical trial. Combined variable: mortality or Ongoing by Low
Antitrombin N=46 patients with confirmed SARS- worsening rate with need for non- 28.04.2020.
CoV-2 respiratory infection with poor invasive mechanical ventilation or with Estimated study
Fundación para la prognostic factors randomized to need for invasive mechanical duration: 6 months
Investigación Biomédica antithrombin or Best available ventilation.
de Córdoba treatment at site
ChiCTR2000030055 Guangdong, Phase 4, blinding not stated. Several primary outcomes Recruiting; Low
Dipyridamidole Hubei, N=460 patients with suspected corona From2020-02-10 To
http://www.chictr.org.c Zhejiang ,China infection but not 2019-nCoV 2020-04-10
n/showproj.aspx?proj=4 pneumonia patients…
9864 Randomised to dipyridamole, or
Conventional treatment
Dipyridamole NCT04391179 United States, Phase 2, randomized, single-blinded Change in D-dimer [ Time Frame: Not yet recruiting Medium
Michigan trial to to evaluate whether 14 days of baseline, up to approximately 28 days
Sponsor: DICER treatment with dipyridamole will after last study drug administration ] Estimated Primary
Yogendra Kanthi reduce excessive blood clotting in Completion Date:
HUM00179783 COVID-19. December 2020
126
Version of 16.06.2020
NCT04389840 Not stated Phase 2/3, randomized, double-blind, Proportion of participants who are alive Not yet recruiting Medium
Dociparstat placebo-controlled study to evaluate and free of invasive mechanical
sodium the safety and efficacy of Dociparstat ventilation [ Time Frame: Through Day Estimated Primary
sodium 28 ] Completion Date:
in patients with Acute Lung Injury (ALI) February 2021
Sponsor:
due to COVID-19.
Chimerix
N=524 subjects with confirmed COVID-
19 who require hospitalization and
supplemental oxygen therapy
randomized 1:1 to Dociparstat sodium
or placebo.
NCT04345848 Switzerland Phase 3, Randomized, single-blinded Composite outcome of arterial or Not yet recruiting Medium
Enoxaparin (outcomes Assessor) trial. venous thrombosis, disseminated
COVID-HEP intravascular coagulation and all-cause Estimated Primary
Sponsor: N=200 hospitalized adults with severe mortality [ Time Frame: 30 days ] Completion Date:
University Hospital, COVID-19. November 30, 2020
Geneva Randomized to therapeutic doses of
enoxaparin or prophylactic doses of
enoxaparin.
Enoxaparin EudraCT: 2020-001708- Italy Phase 3, open-label, prospective Incidence of venous thromboembolism Not yet recruiting Medium
41 (multicentre) controlled randomized trial to detected by imaging [ Time Frame: 30
Sponsor: NCT04366960 determine whether a higher dose of days ] Estimated Primary
Niguarda Hospital low molecular weight heparin Completion Date:
(enoxaparin 40 mg b.i.d.) is superior August 2020
than the standard prophylaxis dose
(enoxaparin 40 mg o.d.) in reducing
thromboembolic events in COVID-19
patients
127
Version of 16.06.2020
Enoxaparin NCT04360824 Not stated Phase 4, randomized, open-label study Mortality [ Time Frame: 30 Days post Not yet recruiting Medium
Thromboprophylaxis comparing standard prophylactic dose intervention ]
enoxaparin (standard of care arm) Estimated Study
Sponsor: University of versus intermediate-dose enoxaparin to Completion Date:
Iowa evaluate safety and efficacy of April 16, 2021
prophylactic anticoagulation therapy
128
Version of 16.06.2020
prophylaxis (Enoxaparin sodium,
Unfractionated heparin and
Fondapariniux) OR therapeutic dose
anticoagulation (Enoxaparin sodium,
Unfractionated heparin, Fondapariniux
and Argatroban)
Enoxaparin NCT04373707 France A phase 4, randomized, open-label Venous thromboembolism [ Time Not yet recruiting Medium
controlled trial to evaluate the Frame: 28 days ]
Sponsor: Central Hospital, effectiveness of weight-adjusted Estimated Primary
Nancy, France prophylactic low molecular weight Completion Date:
heparin doses compared with lower September 2020
fixed prophylactic doses to prevent
venous thromboembolism in COVID-
2019
129
Version of 16.06.2020
Enoxaparin NCT04408235 Italy Multicentre, randomised controlled, Clinical worsening, defined as the Not yet recruiting Medium
open label, two arms study. occurrence of at least one of the
Sponsor: 2020-001972-13 following events, whichever comes first: Estimated Primary
Azienda Ospedaliero- N=300 hospitalized patients with severe [ Time Frame: through study Completion Date: June
Universitaria di Modena COVID-19 pneumonia and coagulopathy completion, up to 30 days ] 2021
not requiring invasive mechanical a. Death
ventilation b. Acute Myocardial Infarction [AMI]
c. Objectively confirmed, symptomatic
Randomisation to Low-Dose LMWH arterial or venous thromboembolism
(Enoxaparin 4000 IU daily) or High-dose [TE]
LMWH (Enoxaparin 70 IU/kg twice d. Need for either non-invasive -
daily) Continuous Positive Airway Pressure
(Cpap) or Non-Invasive Ventilation (NIV)
- or invasive mechanical ventilation for
patients, who are in standard oxygen
therapy by delivery interfaces at
randomisation
e. Need for invasive mechanical
ventilation for patients, who are in non-
invasive mechanical ventilation at
randomisation
Enoxaparin ChiCTR2000030700 China, Hubei Open-label, randomized, parallel trial. Time to Virus Eradication Not yet recruiting Low
Sponsor: (updated 2020-03-10)
Union Hospital affiliated to N=60 hospitalized adult COVID-19
Tongji Medical College of patients randomized 1:1 to Enoxaparin Study execute time:
Huazhong University of Sodium injection and standard 2020-03-09 to 2020-
Science and Technology treatment or standard treatment. 09-30
Enoxaparin EudraCT: 2020-001308- Bologna, Italy Phase II single-arm interventional All cause 30-day mortality Recruiting; Low
40 prospective pilot study
Sponsor: Prof. Pierluigi Safety analysis after
Viale N=100 in the intervention arm first 50 patients in the
interventional study
Interventional group treated with arm
enoxaparin once daily:
60 mg/day BW 45 to 60 kg
80 mg/day BW 61 to 100 kg
100 mg/day BW >100 kg
130
Version of 16.06.2020
thromboembolism prophylaxis in
children hospitalized with SARS-CoV-2.
Products: EudraCT number: Italy Phase 3 Primary objective: Primary completion Medium
1. Low Molecular 2020-001921-30 A multicenter, national, interventional, To assess the hypothesis that an date best guess
Weight Heparin (according to protocol) open label, randomized 1:1:1, adjunctive therapy with steroids and July/August 2020
(enoxaparin) investigator sponsored, three arms unfractionated
LMWH Not in the EU Trials study. heparin or with steroids and molecular Please be aware an
2. Unfractionated Register yet The three treatment arms are: weight heparin (LMWH) are more interim will be made
Heparin UFH 1. LMWH effective in reducing any-cause when 50% has
3. Steroids Short Title: 2. LMWH + steroids mortality in critically-ill patients with completed
(methylprednis STAUNCH-19 3. UFH + steroids pneumonia from COVID- 19 infection
olone) (STeroids And compared to low molecular weight
UNfraCtionated Heparin N= 70 patients in each treatment arm heparin (LMWH) alone.
in covid-19 patients) with critically-ill pneumonia from
Sponsor: COVID- 19 infection Primary endpoint:
All-cause mortality at day 28.
131
Version of 16.06.2020
University Hospital of
Modena, L.go del Pozzo,
71, 41100 Modena- Italy
Prof. Massimo Girardis
Heparin NCT04397510 Not stated Phase 4, randomized, placebo- Mean daily PaO2 to FiO2 ratio [ Time Not yet recruiting Medium
controlled, blinded study to determine Frame: 10 days ]
Sponsor: FHHep518 if nebulized heparin may reduce the Estimated Primary
Frederick Health severity of lung injury caused by COVID- Completion Date:
19. December 31, 2020
132
Version of 16.06.2020
N=80 Adult intensive care patients
(aged 18 years or above)
Confirmed COVID-19 infection
Need for mechanical ventilation
Endothelial biomarker (sTM) > 10
ng/mL
NCT04356833 Not stated A non-randomized, open label, phase II Treatment efficacy - Percentage change Not yet recruiting Low
Plasminogen trial of Nebulised Recombinant Tissue- in PaO2/FiO2 ratio [ Time Frame: 144
Activator Plasminogen Activator (Rt-PA). hours ] Estimated Study
Completion Date:
Nebulised recombinant
N = 24. The first 12 consented patients January 14, 2021
tissue-Plasminogen
will receive nebulised rt-PA in addition
Activator (rt-PA)
to standard of care (SOC). The second
group of 12 patients will receive SOC
Sponsor: University
alone as a comparison
College, London
ChiCTR2000030701 China, A randomized, parallel controlled open- Time to Virus Eradication Not yet recruiting Low
Prolongin Guangdong label trial.
(Enoxaparin Sodium From 2020-03-10 To
Injection) N = 30 hospitalized adult patients with 2020-09-30
novel coronavirus pneumonia.
Sponsor: The Third
People's Hospital of
Shenzhen
Tirofiban, NCT04368377 Italy Phase 2b, Open-label trial on IV P/F ratio, PaO2 difference, 3.A-a O2 Completed Low
Tirofiban, Clopidogrel, Acetylsalicylic difference [Time Frame: At baseline and
Clopidogrel, Acetylsalicylic
acid and Fondaparinux in critically ill 24, 48 and 168 hours after treatment Study Completion
acid, Fondaparinux
patients with Covid-19 initiation] Date: April 23, 2020
Sponsor: University of
N = 5, Age ≥ 18, Covid-19 infected with
Milan
acute severe hypoxic respiratory failure,
D-Dimer value ≥ 3 times the upper level
of normal
ChiCTR2000032135 Shanghai, China Parallel clinical trial mild cases: the critical illness rate of Pending; Low
Ulinastatin N= 50 with mild, severe or critical cases subjects at weeks 2 From 2020-04-22 To
of COVID-19 statified by severity and Severe or critical cases: the Changes of 2020-12-31
A multivalent Kunitz-type ranomdised to ulinastatin or standard PaO2/FiO2 from baseline to day 1, 3, 5
serine protease inhibitor of care and 24 hours later after the last
derived from human urine, administration
with potential protective,
anti-fibrinolytic and
anticoagulant activities.
ACE-2
Product Study identifier Study location Study design Primary outcome Status of trial Importance
133
Version of 16.06.2020
Recombinant human EudraCT: Multi-country Phase 2 study Primary Outcome Measures : Not yet recruiting; High
angiotensin-converting 2020-001172-15 Europe, lead Double-blinded, randomised, placebo- Cause of death or invasive mechanical Estimated Primary
enzyme 2 country: controlled trial. ventilation [ Time Frame: 28 days ] Completion;
Sponsor: APEIRON NCT04335136 Denmark N= 200 Hospitalised Severe Covid-19 The primary endpoint is a composite September 2020
Respiratory Therapies patients randomised to rhACE2 or endpoint of all cause-death or invasive
GmbH APN01-01-COVID19 placebo mechanical ventilation up to 28 days or
hospital discharge
Recombinant Bacterial NCT04375046 Not stated A phase 1, randomized, open label, 1.Time course of body temperature Not yet recruiting Medium
ACE2 receptors -like controlled clinical study to evaluate the (fever) [ Time Frame: 14 days ]
enzyme of B38-CAP recombinant bacterial ACE2 receptors - Estimated Study
(rbACE2) like enzyme 2 (rbace2) compared to 2.Viral load over time [ Time Frame: 14 Completion Date:
standard of care. days ] October 2020
Sponsor: Kafrelsheikh
University N = 24 adult patients with COVID-19
Recombinant Bacterial NCT04382950 Egypt Phase 1, open-label, controlled study on Time course of body temperature Not yet recruiting Low
ACE2 Receptors-Like the use of Recombinant Bacterial ACE2 (fever) [Time Frame: at 14 days]
Enzyme of B38-CAP receptors -like enzyme of B38-CAP Estimated Primary
(rbACE2) and Isotretinoin (rbACE2) plus Aerosolized 13 cis retinoic Completion: July 2020
acid in Covid-19 infection
Sponsor: Kafrelsheikh
University N = 24, with Covid-19 infection
ACE-2 NCT04287686 China, Pilot study to decide whether to Body temperature and viral load Not yet recruiting; Low
Recombinant human Guangdong continue with phase 2B trial Estimated study
angiotensin-converting completion: April
enzyme 2 N=24 patients with positive SARS-CoV-2 2020
Mechanism of action: or homolog to covid19 randomised to Update 06.05.2020:
Recombinant human rhACE2 or placebo Withdrawn
angotensin-converting
enzyme 2 (rhACE2) as a
treatment for patients
with COVID-19 to block
viral entry and decrease
viral replication
Angiotensin 1-7
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Angiotensin 1-7 NCT04332666 Belgium Randomized, controlled, investigator Composite outcome of mortality and Not yet recruiting Medium
ATCO Trial initiated, phase II/phase III, single necessity of mechanical ventilation Estimated Primary
blinded, interventional trial Completion; May 30,
N=60 patients with COVID-19 at ICU 2020
department randomised to angiotensin
(1-7) or placebo
134
Version of 16.06.2020
TXA127 (angiotensin-(1-7)) NCT04401423 Not stated Phase 2 Double-blinded, placebo- Incidence of acute kidney injury [ Time Not yet recruiting Medium
control, randomized clinical trial. Frame: Day 1 to Day 7 ]. Defined as an
Sponsor: Columbia increase of serum creatinine by more Estimated Primary
University This study is to determine if than 0.3 mg/dL or 50% above baseline Completion Date: June
administration of angiotensin-(1-7) / (at enrollment). 2021.
TXA127 prevents acute kidney injury
and deterioration into multi-organ Incidence of respiratory failure [ Time
failure in patients with moderate to Frame: Day 1 to Day 7 ]. Requiring
severe COVID-19. intubation and ventilatory support.
Chloroquine or hydroxychloroquine
Antimalarial agent, heme polymerase inhibitor; Malaria prophylaxis and treatment
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Chloroquin and Early news: EU: France, Adaptive, randomised open clinical trial Subject clinical status (on a 7-point Recruiting; High
Hydroxychloroquin https://www.sciencema Spain, UK, to one of 4 treatments ordinal scale) on Day 15
g.org/news/2020/03/wh Germany, Estimated study
o-launches-global- Belgium, (not Chloroquin in EU) completion: March
megatrial-four-most- Netherlands, 2023
promising-coronavirus- Luxembourg,
treatments Norway, Italy Update May 2020
N=3200 Stopped by WHO
WHO Solidarity and
Discovery ROW: Update June 4 2020,
Argentina, study resumed
NCT04315948 Bahrain,
Canada, Iran,
Canada: NCT04330690 South Africa,
Norway: 2020-000982- Switzerland and
18, NCT04321616 Thailand
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Version of 16.06.2020
Spain: 2020-001366-11 More countries
are expected to
join
Hydroxychloroquine NCT04304053 Barcelona, Phase 3, Open label cluster randomised Incidence of secondary cases among Recruiting; High
Spain trial contacts of a case and contacts of Estimated primary
Sponsor: N= 3040 participants contacts completion: June 15,
Fundacio Lluita Contra la Randomised to prophylaxis with 2020
SIDA Hydroxychloroquine or standard of care
136
Version of 16.06.2020
Chloroquine, NCT04303507 Thailand, Laos, A Randomised 1:1, Placebo-controlled Number of symptomatic COVID-19 Not yet recruiting; High
Sponsor: University of (? and EudraCT number: Vietnam, Italy, Prophylaxis Study (COPCOV) infections [ Time Frame: Approximately Estimated completion
Oxford(Welcome Trust 2020-001441-39?- UK N=40,000 100 days ] date: April 2021
funded) pending Hydroxychloroquine/Chloroquine vs
placebo. Recruits healthcare workers in
healthcare facilities delivering direct
Open for new care to patients with either proven or
sites in Asia, suspected COVID-19, who can be
Europe and
followed reliably for up to 5 months.
Africa
40,000 participants will be recruited
and the investigators predict an average
of 400-800 participants per site in 50-
100 sites.
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Version of 16.06.2020
N=3500 healthcare workers at high risk Estimated Primary
for COVID-19 exposure randomised to 3 Completion: August
arms: 2020
hydroxychloroquine 400 mg once
weekly
hydroxychloroquine 400 mg twice
weekly or
placebo
Hydroxychloroquine NCT04328285 France, A 2-step randomized double-blind Occurrence of an symptomatic or Recruiting; High
and lopinariv/ritonavir d’Angers, Paris, placebo-controlled clinical trial. asymptomatic SARS-CoV-2 infection Estimated Primary
Saint Etienne N=600 health care workers randomised among healthcare workers [ Time Completion:
to HCQ or placebo. Frame: Up to 2.5 months ] November 30, 2020
Subsequently 600 health care workers
will be randomised to Lopinavir and
ritonavir or placebo
Hydroxychloroquine NCT04329923 United States, There are 3 cohorts. All participants in Cohort 1: Median release from Estimated Primary High
Pennsylvania of each the cohorts are randomized to quarantine time [ Time Frame: 14 days Completion: April 1,
one of two arms. or less ] 2021
Cohorts 1 and 3 are double-blind Cohort 2: Rate of hospital discharge [
placebo control cohorts. Cohort 2 is an Time Frame: 14 days ]
open label randomized study.
Cohort 1 (COVID-19 PCR+ patients Cohort 3: Rate of infection [ Time
quarantined at home): HCQ 400 mg x 2 Frame: 2 months ]
vs placebo
Cohort 2 (Hospitalized COVID-19 PCR+
patients): HCQ 600 mg x 2 vs HCQ 600
mg x 1
Cohort 3 (Health care workers at high
risk of contracting COVID-19): HCQ 600
mg x 1 vs placebo
Hydroxychloroquine NCT04329611 Canada, Alberta A Randomized, Double-blind, Placebo- Composite of hospitalization, invasive Recruiting; High
controlled Trial mechanical ventilation or death within Estimated Primary
N=1660 subjects with COVID-19 (clinical 30 days Completion; August
status not stated) randOmised to HCQ 31, 2020
or placebo
Hydroxychloroquine NCT04331834 Barcelona, Pre-Exposure Prophylaxis; Confirmed cases of a COVID-19 Recruiting; High
Spain Randomised, double-blinded controlled Estimated Primary
trial. Completion; October
N=440 High-Risk Healthcare Workers 3, 2020
Hydroxychloroquine NCT04333654 United States, A Phase 1b, Randomized, Double- Viral load assessed by PCR from a Recruiting; High
Massachusetts, blinded, Placebo-controlled Study of nasopharyngeal swab Estimated Primary
Sponsor: Sanofi US Hydroxychloroquine in Outpatient Completion; August,
Adults With COVID-19 2020
N=210
138
Version of 16.06.2020
Hydroxychloroquine NCT04332991 More than 40 Multicenter, blinded, placebo- COVID Ordinal Outcomes Scale (7 step) Recruiting; High
(ORCHID) locations in US controlled, randomized clinical trial on Day 15 [ Time Frame: assessed on Estimated Primary
with COVID-19 study day 15 Completion: April
N=510 randomised to 2021
hydroxychloroquine or placebo
Hydroxychloroquine NCT04334148 Not stated yet Double blind, placebo-controlled, Number of participants testing positive Not yet recruiting; High
randomized clinical trial. for COVID-19 infection [ Time Frame: 30 Estimated Primary
N=15000 Healthcare Workers days ] Completion: July 2020
randomised to Hydroxychloroquine or
placebo
Hydroxychloroquine NCT04336748 Not stated yet Randomized, Double-blind, Controlled Symptomatic or asymptomatic SARS- Not yet recruiting; High
Sponsor: Medical Trial CoV-2 infection confirmed by PCR [ Estimated Primary
University of Vienna N=440 health care workers exposed to Time Frame: 4 weeks ] Completion: July 2020
SARS-CoV-2 randomised to
hydroxychloroquine or placebo
Hydroxychloroquine Eudract: 2020‐001367‐ Denmark A double‐blinded, randomized, All-cause mortality or need of invasive Ongoing High
Baricitinib 88 multistage, mechanical ventilation up to 28 days.
Sarilumab 6‐armed placebo‐controlled trial in the Estimated Primary
Convalescent plasma NCT04345289 framework of Completion: June 15,
an adaptive trial platform. 2021
N=1500
Hydroxychloroquine
Baricitinib
Sarilumab
Hydroxychloroquine; NCT04340544 Germany, Double blinded, placebo-controlled Difference in time to resolution of Not yet recruiting; High
Institute for trial. clinical signs and symptoms of mild Estimated Primary
Sponsor: COMIHY Tropical N=2700 patients with mild COVID-19 COVID-19 [ Time Frame: 28±2 days ] Completion:
University Hospital Medicine randomised to hydroxychloroquine or November 30, 2021
Tuebingen placebo
Hydroxychloroquine NCT04341441 United States, Phase 3, randomized, double-blinded Purpose of the study is to determine Recruiting High
Detroit, (triple-masked) trial, placebo-controlled whether oral HCQ therapy will prevent
Sponsor: Henry Ford Michigan infection Estimated primary
Health System N=3000 health care workers and first completion: June 30
responders randomized 1:1:1 to: 2020
Daily HCQ 200 mg po q following a
loading dose of 400 mg day 1
Weekly HCQ 400 mg po q, or
placebo
Hydroxychloroquine NCT04342221 Germany, Phase 3, randomized, quadruple- Effect of HCQ on in vivo viral clearance Recruiting High
Tübingen masking, placebo-controlled clinical trial [Time Frame: 6 months]
Sponsor: University (COV-HCQ) Estimated primary
Hospital Tuebingen N=220, mild to moderate COVID-19 Completion Date:
patients March 2021
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Version of 16.06.2020
800mg HCQ sulfate on day one and
600mg for 6 more days or
Placebo
Chloroquine Diphosphate NCT04342650 Brazil Phase 2, double-blinded, randomized, Proportion of patients with onset of Recruiting High
placebo-controlled clinical trial. severe acute respiratory syndrome
Sponsor: Fundação de CloroCOVID19II (SARS) [ Time Frame: 7 days after Estimated Primary
Medicina Tropical Dr. N=210 patients, age > 18, without a randomization ] Completion Date:
Heitor Vieira Dourado diagnosis of severe respiratory disease, Evaluate if CQ diphosphate prevents the September 2020
who came to the study site with clinical onset of SARS in patients on
and radiological suspicion of SARS- intervention group through
CoV2. Randomized 1:1 for 5-day standardized questionnaires.
chloroquine diphosphate tablets or
placebo.
Hydroxychloroquine EudraCT: Spain Phase 4, randomized, double-blinded, - The mean reduction in viral load at Ongoing High
sulfate 2020-001587-29 placebo-controlled trial on the efficacy day 14 after recruitment among those
of Hydroxychloroquine sulfate in women infected by SARS-CoV-2, in the Trial registration:
Sponsor: Barcelona preventing SARS-CoV-2 infection and ITT and ATP cohorts, adjusted by age, 2020-04-13
Institute for Global Health CoVid-19 disease severity during gravidity, region(municipality) and
(ISGlobal) pregnancy. other variables associated with the Estimate of duration:
prevalence and viral load of SARS-CoV-2 1 year
N=714 pregnant women in two groups: infection.
a) Pregnant women with PCR-confirmed - The comparison of the proportion of
SARS-CoV-2 diagnosis, with mild or pregnant women who were close
without symptoms/signs suggestive of contacts of confirmed cases of SARS-
the infection CoV-2 infection, with a positive PCR for
b) Pregnant women with a negative PCR the infection at day 14, in the ITT and
SARS-CoV-2 who are contacts (at the ATP cohorts, adjusted by adjusted by
household level) of a confirmed or age, gravidity, region(municipality) and
clinically suspected case of the other variables associated with the
infection. prevalence of SARS-CoV-2 infection.
Hydroxychloroquine NCT04343677 United States, Phase 2, double blinded, randomized, Whether pre-exposure prophylaxis Not yet recruiting. High
Virginia placebo controlled clinical trial to decreases the incidence of COVID-19
Sponsor: United States evaluate the value of using infections amongst personnel [Time Estimated Study
Department of Defense Hydroxychloroquine or Chloroquine as Frame: 2 months] Completion Date: June
pre-exposure prophylaxis or post- 2020
exposure prophylaxis regimen for
COVID-19 patients and at risk
personnel.
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Version of 16.06.2020
Hydroxychloroquine, NCT04344379 France, multiple Phase 3, randomized, double-blinded To assess the impact of Recruiting High
Azithromycin sites trial. hydroxychloroquine and azithromycin
2020-001273-73 on the prevention of SARS-CoV-2 Estimated Primary
Sponsor: N=900 hospital workers with no signs of contamination in hospital workers Completion Date:
Assistance Publique - PREP-COVID COVID-19 randomized 1:1:1 to exposed to 40 days of treatment. [ Time July 31, 2020
Hôpitaux de Paris hydroxychloroquine or azithromycin or Frame: 3 months ]
placebo of hydroxychloroquine.
Hydroxychloroquine, NCT04345861 France Double-blinded randomized, placebo- Time to clinical improvement of at least Recruiting High
azithromycin COVIDOC controlled clinical trial to evaluate the 1 level on the ordinal scale between
efficacy and safety of Day 1 (day of the first administration of Estimated Primary
Sponsor: hydroxychloroquine combined with study drug) to Day 11 (day after last day Completion Date:
University Hospital, azithromycin compared to of treatment). September 6, 2020
Montpellier hydroxychloroquine monotherapy in Evaluation of the clinical status of
patients hospitalized with confirmed patient defined by the Ordinal Scale of
COVID-19 pneumonia. 7 points (score range from 1 to 7 , with
7 being the worst score)
N=150 randomized to [ Time Frame: up to Day 11 ]
Hydroxychloroquine + placebo or
hydroxychloroquine + azithromycin
Hydroxychloroquine, NCT04346667 Pakistan Phase 4, double-blind, randomized trial RT-PCR negative status [ Time Frame: 6- Recruiting High
Chloroquine to evaluate the use and dosage of 7 days ]
hydroxychloroquine and chloroquine to Estimated Primary
Sponsor: convert RT-PCR positive COVID-19 Completion Date: May
Government of Punjab, patients to RT-PCR-negative as a means 30, 2020
Specialized Healthcare and to reduce hospitalization rate.
Medical Education
Department N=400 randomized to
Hydroxychloroquine Sulfate Regular
dose + standard of care or
Hydroxychloroquine Sulfate Loading
Dose + standard of care or Chloroquine
+ standard of care or placebo +
standard of care
Hydroxychloroquine NCT04349228 Tunisia Phase 3 randomized parallel Symptomatic COVID(+) infection rate Not yet recruiting High
interventional open-label blinded [Time Frame: 60 days]
Sponsor: Abderrahmane placebo controlled clinical trial to assess Estimated Primary
Mami Hospital the Efficacy and Safety of Completion Date: July
Hydroxychloroquine (HCQ) 15, 2020
Administered as a Prophylaxis for
Health Professionals Exposed to
COVID19.
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Version of 16.06.2020
mg / day) for at least 2 months or until
potential contamination, or placebo.
Hydroxychloroquine NCT04358081 USA Quadroblinded RCT with 3 treatment Percentage of [patients hospitalized Recruiting from April High
(HCQ): malaria, amoebae, Sponsor:Novartis (FDA-approved) arms. 444 patients randomized 1:1:1 to with COVID19 pneumonia.] who 30, 2020
SLE, RA. Standard of care plus achieve clinical response (i.e. to Estimated study
Azithromycin (AZT): 1) placebo demonstrate in patients receiving completion:
Macrolide antibiotic. 2) oral HCQ monotherapy standard of care that the percentage July 21, 2020
Infection with AZT- 3) oral HCQ + AZT who achieve clinical response with
sensitive bacteria hydroxychloroquine or
hydroxychloroquine and azithromycin is
superior to placebo at Day 15)
Chloroquine NCT04351191 Pakistan Prospective double blind randomized RT-PCR negative status [ Time Frame: Recruiting; High
Hydroxychloroquine superiority clinical trial 6th and 7th day ] Estimated Primary
(PRECISE) N=400 patinets with non-life Completion; May 30,
Sponsor: threatening symptomatic SARS-CoV-2 2020
Government of Punjab, infection randomized to
Specialized Healthcare and Hydroxychloroquine sulfate regular
Medical Education dose,
Department hydroxychloroquine sulfate loading
dose,
chloroquine, or
placebo
Hydroxychloroquine NCT04352933 UK Phase 3, double-blind, randomized, Time to positive COVID-19 disease Recruiting High
placebo-controlled trial for [Time Frame: Assessed up to 90 days]
Sponsor: Cambridge EudraCT 2020-001331- Hydroxychloroquine as Estimated primary
University Hospitals NHS 26 chemoprophylaxis for COVID-19 completion date:
Foundation Trust infectious disease. October 31, 2020
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care workers in the hospital reduces Estimated primary
symptomatic and asymptomatic COVID- completion date: June
19 disease during the pandemic. 24, 2020
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Version of 16.06.2020
treatment allocation
(Hydroxychloroquine, Azithromycin or
placebo)
Hydroxychloroquine NCT04363450 United States, A phase 3, double-blind, randomized, Incidence of symptomatic COVID-19 Recruiting High
Louisiana placebo-controlled clinical trial to infection in healthcare workers [ Time
Sponsor: Louisiana State (HCQPreP) determine if primary prophylaxis with Frame: 12 weeks ] Estimated primay
University Health Sciences hydroxychloroquine in healthcare Completion Date: July
Center in New Orleans workers reduces symptomatic COVID- 6, 2020
19 infection
N = 960
Hydroxychloroquine NCT04372017 Not stated? A phase 3, double-blind, randomized, 1.Cohort A: Percentage of COVID-19 Not yet recruiting High
placebo-controlled study in two distinct exposed healthcare workers treated
Sponsor: Sanford Health cohorts to evaluate the efficacy and with hydroxychloroquine with a positive Estimated Primary
safety of hydroxychloroquine in the COVID-19 test. Completion Date:
prevention of COVID-19 infection. 2.Cohort B: Percentage of COVID-19 April 20, 2022
exposed high-risk individuals treated
N = 1739 allocated to 4 arms. with hydroxychloroquine with a positive
Arm 1: Experimental: Cohort A: COVID-19 test.
Healthcare worker
(hydroxychloroquine)
Arm 2: Placebo Comparator: Cohort A:
Healthcare worker (placebo)
Arm 3: Experimental: Cohort B: High-
Risk participant (hydroxychloroqine)
Arm 4: Placebo Comparator: Cohort B:
High-Risk participant (placebo)
Hydroxychloroquine NCT04370015 Pakistan Double-blinded, placebo-controlled, 1. Prevention of SARS-CoV-2 as Not yet recruiting High
Chemoprophylaxis randomized trial on the efficacy of HCQ determined by negative RT-PCR at the
in prophylaxis of Covid-19 infection if end of 12 week study period Estimated primary
Sponsor: Services Institute health care workers at risk of exposure Completion, July 2020
of Medical Sciences, 2. Safety as determined by presence or
Pakistan absence of any adverse event related
with hydroxychloroquine treatment
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Version of 16.06.2020
N = 274, age ≥ 18 ≤ 60, health care
workers without Covid-19 randomized [Time Frame: From date of
to oral HCQ or placebo for 11 weeks randomization until the appearance of
symptoms or study completion 12
weeks after treatment initiation]
Hydroxychloroquine NCT04369742 United States, Phase 2, double-blinded, placebo- 1. Cumulative incidence of SAEs and Recruiting High
New York controlled, randomized trial on HCQ in grade 3 or 4 AEs through day 30 [Time
Sponsor: NYU Langone adults hospitalized with Covid-19 Frame: 30 days] Estimated Primary
Health Multicenter Completion: June
N = 626, age ≥ 18, hospitalized with 2. Incidence of discontinuation of 2020
Covid-19 randomized 1:1 to HCQ or therapy [Time Frame: 30 days]
placebo (calcium citrate)
3. Severe disease progression [Time
Frame: 14 days]
Hydroxychloroquine NCT04371523 Canada, Ontario A phase 3, randomized, double blind, Positive for SARS-CoV-2 [ Time Frame: 8 Not yet recruiting High
parallel design, placebo controlled trial weeks ]
Sponsor: St. Joseph's (PROVIDE) to prevent COVID-19 disease amongst Estimated primary
Healthcare Hamilton healthcare workers. Completion Date: July
31, 2020
N = 1000 healthcare workers
Hydroxychloroquine NCT04374942 Canada, Ontario A phase 3, double-blind, randomized Microbiologically confirmed COVID-19 Enrolling by invitation High
placebo controlled trial to evaluare if (SARS-CoV-2 infection) [ Time Frame:
Sponsor: Megan Landes (HEROs) hydroxychloroquine taken once daily Samples collected at day 0, 30, 60, 90 Estimated Study
for three months as PrEP can prevent and 120 ] Completion Date:
COVID-19 in health care workers in the January 30, 2022
emergency department.
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Version of 16.06.2020
N = 132 age > 18 to 400mg
hydroxychloroquine daily with at least
10 radiation treatments prior to
initiation of hydroxychloroquine.
Hydroxychloroquine NCT04385264 Switzerland Phase 2/3, double-blinded, placebo- Proportion of poor outcomes (in index Not yet recruiting High
controlled, randomized trial on the cases) [Time Frame: During the period
Sponsor: Center for efficacy of early HCQ in outpatients to that the subject is considered as COVID- Estimated Primary
Primary Care and Public reduce secondary hospitalisation and 19-positive: Average of 11 days] Completion: August
Health (Unisante), household transmission of COVID-19 2020
University of Lausanne, Proportion of secondary
Switzerland N = 800, Covid-19 infected, well enough hospitalisations (and their length), ICU
to self-isolate in Switzerland admissions (and their length) and
deaths.
Hydroxychloroquine NCT04397328 Not stated Phase 3, randomized, double-blinded Incidence of symptomatic fever >37.8, Not yet recruiting High
study to assess the safety and efficacy dry cough, or shortness of breath
Sponsor: of post-exposure prophylaxis with (resident/patient report or nurse Estimated Primary
Lawson Health Research hydroxychloroquine for the prevention observation) respiratory infection with Completion Date:
Institute of Coronavirus Infectious Disease-19 confirmed PCR+ result for SARS-CoV-2. [ April 30, 2021
(COVID-19) in high-risk older individuals Time Frame: baseline through day 90 ]
in long-term and specialized care.
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Version of 16.06.2020
receive the intervention, being all
participants measured regularly. This
process continues until all the clusters
have received the intervention.
Hydroxychloroquine + 2020-001265-36 Ireland a multi-centre, prospective, a composite endpoint for time to Ongoing; Medium
azithromycin randomised, open label, 3 arm (ratio progression to intubation, non-invasive
1:1:1) trial with parallel group design. ventilation, use of immunomodulatory Estimated primary
Sponsor: University therapy for COVID-19 infection or completion: May 2022
College Dublin N=351 Patients with confirmed death.
diagnosis of COVID-19 (PCR positive)
who are non-critical but show evidence
of progressive clinical decline will be
randomised to
standard of care + HCQ,
Standard of care+ HCQ + azithromycin,
or
standard of care.
Hydroxychloroquine, 2020-001363-85 Denmark A randomised, open label, controlled SARS-CoV-2 positive rtPCR from Start date 23.04.2020. Medium
vitamin D and Zinc trial. nasopharyngeal samples during 2 Duration of the trial: 4
N=206 Danish nursing home residents, months prophylactic treatment with months
healthy volunteers randomised to hydroxychloroquine, vitamin D, and zinc
hydroxychloroquine, vitamin D, and zinc supplement or no prophylactic
supplement or treatment
no prophylactic treatment
Hydroxychloroquine Eudract: 2020-001257- Denmark A multicenter parallel-group open Hospitalization due to SAR-COV-2 Ongoing Medium
51 randomized clinical trial
Hydroxychloroquine, NCT04392128 France Phase 2, multicentric, placebo- Evaluation of the efficacy of Not yet recruiting Medium
Azithromycine controlled double-blind, randomized hydroxychloroquine and
2020-002002-45 study to evaluate the efficacy of the azithromyncine on the viral load drop at Estimated Primary
Sponsor: combination of hydroxychloroquine and day 5. [ Time Frame: 5 days of Completion Date:
Institut de Cancerologie azithromycine on the viral load drop at treatment ] December 31, 2020
Strasbourg Europe day 5 among patients with COVID-19
and hematological malignancies.
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Hydroxychloroquine and NCT04411433 Turkey Phase 3, open-label, multicenter, 1. Time to recovery (discharge) [ Time Recruiting Medium
Favipiravir parallel-group, randomized study to Frame: 14 days ]
evaluate the efficacy and safety of Estimated Primary
Sponsor: Hydroxychloroquine and Favipiravir in 2. Decrease in viral load [ Time Frame: Completion Date: July
Ministry of Health, Turkey the treatment of mild to moderate 14 days ] 30, 2020
COVID-19.
Hydroxychloroquine, 2020-001605-23 Spain Phase IV, randomized, open-label study Respiratory severity scale Brescia- Ongoing Medium
Azithromycin, to evaluate the effectiveness of the COVID. During hospital admission.
Lopinavir/ritonavir HUA-COVID-19 combined treatment with Estimated primary
hydroxycloroquine and azithromycin vs completion date:
Sponsor: lopinavir/ritonavir + hydroxycloroquine 2020-12-31
Basque Health Service in hospitalized patients with confirmed
COVID-19 infection.
148
Version of 16.06.2020
IDIVAL Instituto de in SARS CoV2 infection in hospital [Time frame: 2 months] 2020-11-21
Investigación Sanitaria healthcare personnel.
Valdecilla
N=450 healthcare personnel with high
risk exposure randomized to
hydroxychloroquine or placebo.
Hydroxychloroquine NCT04392973 Saudi Arabia Randomized, open-label, parallel Clinical Improvement [ Time Frame: 28 Not yet recruiting Medium
groups multi-centered trial to evaluate days ]
Sponsor: FACCT the efficacy of the combination of Estimated Primary
King Abdullah Favipiravir and Hydroxychloroquine as Completion Date:
International Medical potential therapy for moderate and November 2021
Research Center severe cases with COVID-19
149
Version of 16.06.2020
Hydroxychloroquine 2020-001697-30 Spain Phase 3, randomized, controlled, open- - Appearance of Ig M in rapid test YES / Ongoing Medium
label trial to assess the efficacy and NO
Sponsor: COVIDNA safety of hydroxychloroquine base as - Appearance of Ig G in rapid test YES / Estimated primary
NAVARRABIOMED - prophylaxis in health professionals NO completion date:
FUNDACIÓN MIGUEL subjected to repeated exposures to the - Appearance of symptoms compatible 2020-08-07
SERVET COVID-19 virus. with COVID-19
- Positive PCR with compatible
N=200 healthy sanitary with high symptoms carried out in occupational
exposure to COVID-19 randomized to risks (YES / NO)
hydroxychloroquine or no treatment. [Time frame: 6 weeks]
Hydroxychloroquine NCT04389359 United Kingdom Phase 2/3, open-label, controlled, Time to confirmed diagnosis of COVID- Not yet recruiting Medium
randomized trial on the use of HCQ as 19 [Time Frame: To study completion,
Sponsor: Cambridge prophylaxis for Covid-19 in vulnerable average 6 months] Estimated Primary
University Hospitals NHS patient groups Completion: August
Foundation Trust 2021
N= 1500, in the high risk population
group with no previous confirmed
Covid-19 diagnosis
Hydroxychloroquine NCT04382625 United States, A phase 4, randomized open-label trial 1.Change from Baseline Oxygenation on Not yet recruiting Medium
Idaho of hydroxychloroquine + usual care Day 1 to Day 5 [ Time Frame: Day 1 of
Sponsor: Kootenai Health compared to usual care. treatment to day 5 of treatment ] Estimated Primary
paO2 Completion Date:
N = 120 hospitalized adults with 2.Change from Baseline Oxygenation at January 1, 2022
confirmed SARS-CoV-2 infection and Day 5 [ Time Frame: Day 1 of treatment
acute hypoxia to day 5 of treatment ]
FIO2
Hydroxychloroquine, 2020-002123-11 Spain Phase 4, randomized, controlled, open- Rate of patients achieving complete Ongoing Medium
Cycosporine label trial to evaluate the efficacy of response 3 months after being
HUIS-04-2020 cyclosporine and hydroxychloroquine diagnosed of COVID-19 pneumonia Estimated primary
Sponsor: (treatment group) versus [Time frame: 3 months] completion: 2021-05-
Tatiana Cobo Ibáñez, hydroxychloroquine (control group) in 08
Gemma María Mora patients with acute COVID-19
Ortega and Gonzalo pneumonia.
Serralta San Martín
N=280 randomized to cyclosporine +
hydroxychloroquine or
hydroxychloroquine alone.
Hydroxychloroquine + Zinc NCT04377646 Tunesia Phase 3, randomized, controlled, Frequency of confirmed SARS CoV2 Not yet recruiting Medium
(multicenter) double-blinded clinical trial aiming to infection [ Time Frame: At 2 months of
Sponsor: assess the efficacy of follow-up ] Estimated Primary
Military Hospital of Tunis hydroxychloroquine associated to Zinc Completion Date: May
compared to hydroxychloroquine in the 24, 2020
prevention of COVID-19 infection.
150
Version of 16.06.2020
Hydroxychloroquine + Zinc or
Hydroxychloroquine or placebo.
Hydroxychloroquine NCT04379492 United States, A phase 2, randomized double-blind, 1.Clinical improvement on the Ordinal Recruiting Medium
New York placebo-controlled study of Scale for Clinical Improvement (OSCI) [
Sponsor: Memorial Sloan hydroxychloroquine compared to Time Frame: 14 days ] Estimated Primary
Kettering Cancer Center placebo as treatment for severe acute 2.Number of participants requiring Completion Date: May
respiratory syndrome coronavirus 2 mechanical ventilation for respiratory 2021
(SARS-CoV-2) infection. failure [ Time Frame: 14 days ]
N = 120
Hydroxychloroquine, NCT04374019 United States, Phase 2, Open-label, randomized trial of Clinical Deterioration [Time Frame: 14 Recruiting Medium
Azithromycin, Ivermectin, Kentucky Novel Agents for Treatment of High-risk days]
Camostat Mesilate COVID-19 Positive Patients Estimated Study
Completion: May 2021
Sponsor: Susanne Arnold N = 240, with confirmed Covid-19 or
high probability of Covid-19 randomized
to 4 arms:
Arm A: HCQ
Arm B: HCQ + Azithromycin
Arm C: HCQ + Ivermectin
Arm D: Camostat Mesilate
Hydroxychloroquine NCT04374552 United States, A phase 2, randomized, double-blinded, The primary outcome is the rate of Not yet recruiting Medium
sulfate and Azithromycin New Jersey placebo-controlled study comparing decline in viral load over the 10 days
azithromycin and hydroxychloroquine after randomization [ Time Frame: 10 Estimated Study
Sponsor: Rutgers, The vs placebo. days ] Completion Date:
State University of New April 2021
Jersey N = 140 asymptomatic volunteers with
COVID-19
Hydroxychloroquine, NCT04372082 France Phase 3, multicenter, randomized, 1. death [ Time Frame: At day 14 ] Not yet recruiting Medium
Diltiazem-Niclosamide open-labeled controlled trial.
2020-002188-72 2. clinical worsening (composite Estimated Study
Sponsor: N=480 adult with positive test of covid- criteria) [ Time Frame: At day 14 ] Completion Date: May
University Hospital, Lille HYdILIC 19, asymptomatic or with symptoms 2023
lasting less than 8 days, and associated 3. Assisted-ventilation and/or
comorbidities without any severity hospitalization (composite criteria) [
criteria of the disease at inclusion. Time Frame: At day 14 ]
Randomized to hydroxychloroquine +
standard of care or Diltiazem-
Niclosamide + standard of care or
standard of care only.
Hydroxychloroquine, NCT04359953 France Phase 3, open-label, randomized trial to Two-weeks survival rate [ Time Frame: Not yet recruiting Medium
Telmisartan and evaluate the efficacy of Day 14 ]
Azithromycin Hydroxychloroquine, Telmisartan and Estimated Primary
Azithromycin on the survival of Completion Date: June
Sponsor: 1, 2021
151
Version of 16.06.2020
University Hospital, hospitalized elderly patients with
Strasbourg, France COVID-19.
N=1600 randomized to
Hydroxychloroquine or Azithromycin or
Telmisartan or usual care.
Hydroxychloroquine and NCT04371406 France? A phase 3, randomized, controlled, 1.Rate of patients with occurrence of an Not yet recruiting Medium
Azithromycin open-label trial to assess the efficacy of unfavorable outcome between
Hydroxychloroquine combined with randomization and day 14 Estimated primary
Sponsor: Assistance azithromycin in COVID-19 patients in 2.Primary outcome of ancillary Completion Date:
Publique - Hôpitaux de primary care, in add-on to standard of virological study : evolution of viral load August 2, 2020
Paris care (Azinc) between day 0 and day 14
N = 2770
Hydroxychloroquine + zinc NCT04370782 United States, A phase 4 randomized, open-label trial 1.Time to Resolution of Symptoms Not yet recruiting Medium
combined with either New York to assess the safety and efficacy of relative to baseline (day 1 of trial)
azithromycin or hydroxychloroquine, and zinc in 2.Time to Resolution of Symptoms Estimated Primary
doxycycline combination with either azithromycin relative to baseline (day 1 of trial) Completion Date:
or doxycycline 3.Time to Resolution of Symptoms August 31, 2020
Sponsor: St. Francis relative to baseline (day 1 of trial)
Hospital, New York N = 750 high risk COVID-19 positive 4.Number of participants hospitalized
outpatients and/or requiring repeat ER visits
5.ICU Length of Stay
6.Ventilator
Hydroxychloroquine ChiCTR2000032487 China, Hubei Phase 4, stratified block randomization. Detection of nucleic acid and antibody Not yet recruiting Medium
sulfate of new coronavirus
Blinding not stated. From 2020-03-01 to
Sponsor: 2020-09-30
Shanghai Public Health N=2000 healthy COVID-19 negatve
Clinical Center subjects randomized to
hydroxychloroquine sulfate or placebo.
Hydroxycholoroquine NCT04370262 United States, Phase 3, Randomized, Double-Blind, Mortality [ Time Frame: 30 days post Recruiting Medium
(HCQ), Famotidine New York Multi-Arm Historical Control hospitalization ]
(multiple sites) comparative trial of the safety and Estimated primary
Sponsor: efficacy of Hydroxychloroquine and the Completion Date: Sept
Northwell Health combination of HCQ and Famotidine for 7, 2020
the treatment of COVID-19.
N=1170 randomized to
HCQ/Famotidine or HCQ/Placebo or
control group (historical control,
hospitalized patients who were not
treated with hydroxychloroquine or
famotidine during the early stages of
the pandemic because
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Version of 16.06.2020
hydroxychloroquine was not a part of
the standard of care).
Azithromycin, NCT04365582 France A phase 3, open label randomized Hospital admission [ Time Frame: Day Not yet recruiting Medium
Hydroxychloroquine and clinical trial comparing 4 arms of 20 ]
Lopinavir treatment: Standards of Care (SoC) Estimated primary
alone versus SoC + Azithromycine Completion Date: July
Sponsor: Groupe versus SoC + Hydroxychloroquine vs Soc 28, 2020
Hospitalier Paris Saint + Lopinavir/Ritonavir
Joseph
N = 640 patients more than 50 years of
age with comorbidity or patients more
than 70 years of age.
Hydroxychloroquine NCT04364022 Switzerland A phase 3, open-label, randomized 21-day incidence of COVID-19 in Recruiting Medium
Sulfate and clinical trial to evaluate the efficacy of a individuals exposed to SARS-CoV- 2 who
Lopinavir/ritonavir (COPEP) single-dose of HCQ treatment and of a are asymptomatic at baseline (intent- Estimated Study
5-day course of LPV/r treatment in to-treat (ITT) analysis). [ Time Frame: Completion Date:
Sponsor: Calmy Alexandra preventing COVID-19 in asymptomatic 21-day ] October 2020
individuals exposed to a SARS-CoV-2
documented index patient, compared
to surveillance alone.
N = 420
Chloroquine Sulfate, NCT04362332 Netherlands Phase 4, cluster randomized, open-label Composite endpoint with disease Recruiting Medium
Hydroxychloroquine trial. progression defined as a NEWS2score ≥
7 within 14 days or resulting in
Sponsor: N=950 hospitalized patients ≥18 with admission to Intensive/Medium Care
UMC Utrecht moderate to severe COVID-19 cluster unit or resulting in death within 14
randomized to chloroquine+standard- days. [ Time Frame: 14 days ]
supportive-care or
hydroxychloroquine+standard-
supportive-care or standard-supportive-
care only.
Hydroxychloroquine, NCT04361461 Brazil Phase 3, randomized, open-label trial to Individual response rate [ Time Frame: Not yet recruiting Medium
Azythromycin evaluate the safety and efficacy of the 14 days after randomization ]
hydroxychloroquine in patients with Estimated Primary
Sponsor: symptomatic SARS-Cov2. Completion Date:
Apsen Farmaceutica S.A. November 4, 2020
N=500 hospitalized covid-19 patients >
18 years randomized to
Hydroxychloroquine or
Hydroxychloroquine + azithromycin.
Chloroquine or NCT04360759 South Africa Phase 3, open-label, multi-centre Event-free survival at 28 days post- Not yet recruiting Medium
hydroxychloroquine randomised controlled trial of randomization between experimental
Chloroquine/Hydroxychloroquine group and standard of care group [ Estimated Study
Sponsor: University of versus standard of care. Time Frame: Day 28 ] Completion Date: July
Cape Town 31, 2021
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Version of 16.06.2020
N = 560 HIV-positive outpatients with
mild Covid-19 in
Hydroxychloroquine NCT04354441 Canada?? Phase 2, randomized, placebo- COVID-19-related hospital admissions [ Not yet recruiting Medium.
controlled, double blinded trial to Time Frame: Hospital Admission at any
Sponsor: HyPreC evaluate the effect of outpatient point from study enrollment to delivery Estimated Primary
Sir Mortimer B. Davis - Hydroxychloroquine on reducing ] Completion Date:
Jewish General Hospital hospital admissions in pregnant women November 2020
with SARS-CoV-2 infection.
N=40 randomized to
Hydroxychloroquine+ Azithromycin or
Hydroxychloroquine.
Hydroxychloroquine, NCT04355052 Israel Phase 3, open-label, randomized trial. 1. clinical state as reflected by NEWS Recruiting Medium
Azithromycin, Camostat scoring [ Time Frame: 7 days ]
Mesylate N=250 hospitalized patients suffering Estimated Primary
from a mild or moderate SARS-CoV-2 2. positive PCR [ Time Frame: 7 days ] Completion Date:
Sponsor: virus randomized to October 11, 2020
Sheba Medical Center Hydroxychloroquine+Azithromycin or
Hydroxychloroquine+Camostat
mesylate or nothing (control)
Hydroxychloroquine NCT04359537 Not stated Phase 2, randomized, blinded, clinical COVID-19-free survival in experimental Not yet recruiting Medium
trial to compare the efficacy of various arms compared to placebo [ Time
Sponsor: Shaheed Zulfiqar (CHEER) doses of Hydroxychloroquine in pre- Frame: 12 weeks ] Estimated primary
Ali Bhutto Medical exposure prophylaxis for COVID 19 in Completion Date:
University healthcare personnel August 25, 2020
154
Version of 16.06.2020
Arm 2:Hydroxychloroquine 400 mg on
day 1
Arm 3:Hydroxychloroquine 200 mg on
day 1
Control Group :Placebo
Hydroxychloroquine (HCQ) NCT04354597 Jordan A multicenter, randomized, open-label, Effect of HCQ and AZ in preventing Not yet recruiting Medium
and Azithromycin (AZ) pilot study on using HCQ and AZ infection with COVID-19 among
MOPHYDA prophylaxis for healthcare workers with healthcare workers working with Estimated Primary
Sponsor: a potential risk of exposure to COVID-19 COVID-19 patients [ Time Frame: 4 Completion Date:
Iyad Sultan, King Hussein patients. months ] August 15, 2020
Cancer Center
N=200 healthcare workers dealing with
COVID-19 patients randomized to HCQ
& AZ or no treatment.
Hydroychloroquine NCT04353037 United States, Phase 2, randomized, open-label, multi- Patients: Rate of hospitalization at 21 Recruiting Medium
New York arm blinded trial of Hydroxychloroquine days
Sponsor: UnitedHealth in the Prevention and Treatment of Health care workers: Rate of COVID-19 Estimated Study
Group COVID-19 infection (confirmed by accepted Completion Date: June
testing methods) at 2 months 15, 2021
N = 850
A) patients age 50-75 with symptoms of
COVID-19 to hydroxychloroquine 400
mg bid (two 200 mg tablets taken twice
a day; totaling 800 mg per day) for two
weeks or placebo.
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Version of 16.06.2020
N = 1057 patients aged 65 years or
above with Symptomatic SARS-CoV-2
Infection .
Participants will be randomly allocated
1:1 to the following strategies:
•Arm 1: control arm
•Arms 2 to X (where X is the number of
arms): Experimental treatment At the
time of trial initiation: People in the
control arm will receive a complex of
vitamins; people in the experimental
arms will receive hydroxychloroquine,
or favipiravir, or imatinib, or
telmisartan.
Chloroquine/ NCT04351724 Austria A randomized, controlled, open-label Sustained improvement (>48h) of one Recruiting Medium
Hydroxychloroquine, (multiple sites) trial on the efficacy and safety of point on the WHO Scale [ Time Frame:
Lopinavir/Ritonavir, ACOVACT experimental therapeutics for patients Inclusion to day 29, daily evaluation ] Estimated Primary
Rivaroxaban, with COVID-19. Completion Date:
Thromboprophylaxis, December 1, 2020
Candesartan, N=500 randomized to receive
Clazakizumab hydroxychloroquine or
lopinavir/ritonavir or standard of care.
Sponsor: Moreover, these patients are eligible
Medical University of for substudy A (randomized to
Vienna rivaroxaban 5mg 1-0-1 vs. standard of
care), substudy B (renin-angiotensin
(RAS) blockade vs. no RAS blockade for
patients with blood pressure
>120/80mmHg), and substudy C
(clazakizumab vs. standard of care, for
patients with respiratory deterioration
and high inflammatory biomarkers).
Chloroquine phosphate ChiCTR2000031204 China, Beijing Phase 2, single-blind, randomized Clearance time of virus RNA Recruiting Medium
(multicenter) controlled clinical trial to evaluate the
Sponsor: efficacy and safety of chloroquine From 2020-01-30 To
Beijing you'an Hospital, phosphate against pneumonia caused 2020-04-30
Capital Medical University by novel coronavirus.
Chloroquine NCT04349371 United States, Phase 2 randomized placebo controlled 1.Number of symptomatic illness in at Recruiting Medium
New York clinical trial to determine the clinical risk healthcare workers [Time Frame:
Sponsor: Columbia efficacy of Chloroquine (CQ) in health Up to 3 months]
University care workers with moderate to high risk
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Version of 16.06.2020
of exposure to COVID-19 in preventing 2.Number of healthcare workers with Estimated Study
symptomatic COVID-19 infections. symptomatic COVID infections [Time Completion Date:
Frame: Up to 3 months] April 2021
N = 350 healthcare workers at New
York Presbyterian Hospital with possible 3.Number of severe illness in at risk
exposure for COVID-19 infection at least healthcare workers [Time Frame: Up to
2 days a week >/= 8 hours a day to 3 months ]
receive chloroquine supply of 36 - 250
mg tabs or placebo that will last 3
months (enough for taking two tabs of
250mg for every day for one week and
then two tabs of 250mg for 1 day a
week thereafter for study duration of 3
months).
Hydroxychloroquine NCT04351516 Germany A phase 2/3 randomized, blinded, Rate of hospitalization or death at day 7 Recruiting Medium
placebo-trial of Hydroxychloroquine after study inclusion [ Time Frame: 7
Sponsor: University (COVID65plus) versus placebo days ] Estimated Study
Hospital Tuebingen Completion Date: May
N = 350 elderly COVID19 patients (equal 1, 2021
or older than 65 years)
Hydroxychloroquine, NCT04347512 France Phase 3, randomized, open-label study Rate of patients reaching a significant Not yet recruiting Medium
azithromycin to evaluate the clinical impact of adding hypoxemia, in each arms. [ Time Frame:
Azithromycin to Hydroxychloroquine in From day 0 to day 7 ] Estimated Primary
Sponsor: the treatment of Sars-CoV-2 Completion Date:
University Hospital, pneumonia. August 1, 2021
Strasbourg, France
N=405 randomized to
Hydroxychloroquine+ Azithromycin or
Hydroxychloroquine or nothing (control
group).
Hydroxychloroquine, NCT04344444 United States, Phase 3, randomized, open-label trial. Most severe outcome [ Time Frame: 5 Recruiting Medium
Azithromycin Louisiana days ]
N=600 COVID-19 infected patients with Ordinal outcome of most severe a Estimated Primary
Sponsor: early moderate and severe disease patient experienced after inpatient Completion Date:
LCMC Health admitted to the hospital. admission April 10, 2021
157
Version of 16.06.2020
HCQ 400mg po BID x 1 day, then 200mg
po BID x 4 days or placebo
Sarilumab, Azithromycin, NCT04341870 France, Paris (4 Phase 2/3 bayesian, open-label, Need for ventilation (invasive and non- Recruiting Medium
Hydroxychloroquine hospitals) randomized 1:1 clinical trial of invasive), intensive care or death [time
(CORIMUNO-VIRO) Sarilumab in combination with frame: 14 days] Estimated primary
Sponsor: Assistance Azithromycin and HCQ compared to completion date: May
Publique - Hôpitaux de only Sarilumab 2020
Paris
N=60, patients with moderate, severe
COVID-19 pneumonia
Hydroxychloroquine NCT04342156 Singapore Phase 3, Open-label, randomized trial of Number of infected household contacts Not yet recruiting Medium
HCQ as prophylaxis for at-risk of confirmed COVID-19 patients under
Sponsor: Tan Tock Seng population home quarantine. Estimated primary
Hospital completion date:
N=3000 Positive serology or reverse August 2020
transcriptase (RT-PCR) for COVID-19 up
Group one: Oral HCQ post-exposure- until day 28
prophylaxis taken over 5 days
Group two: no treatment
Hydroxychloroquine NCT04341727 USA Phase 3, open-label, randomized, 4- Hours to recovery [ Time Frame: 42 Recruiting Medium
sulfate, Chloroquine armed trial. days ]
sulfate, Azithromycin 202003188 Estimated Primary
N=500 non-critically ill hospitalized Completion Date:
Sponsor: Washington participants (not requiring mechanical April 1, 2021
University School of ventilation) with SARS CoV-2 infection
Medicine randomized to hydroxychloroquine or
chloroquine with or without
azithromycin.
Hydroxychloroquine, NCT04338698 Pakistan Adaptive, double blinded, randomized Test negative day 7 Not yet recruiting; Medium
Oseltamivir and controlled trial. 8 arm study
Azithromycin N=500 randomised to: The clinical primary outcome will be Estimated primary
Hydroxychloroquine, improvement of two points on a seven- completion: Sept 2020
Sponsor: Shehnoor Azhar, Azithromycin, category ordinal scale.
Federal Task Force on Oseltamivir,
Science & Technology Hydroxychloroquine + Azithromycin,
notified by Government of Hydroxychloroquine + Oseltamivir,
Pakistan Azithromycin + Oseltamivir,
Hydroxychloroquine + Azithromycin +
Oseltamivir, or
No intervention
Hydroxychloroquine vs NCT04334382 United States, Open label randomised controlled trial. Hospitalization within 14 days of Recruiting; Medium
azithromycin Utah N=1550 outpatients with COVID-19 enrollment Estimated Primary
randomised to hydroxychloroquine or Completion:
azithromycin December 31, 2020
Hydroxychloroquine vs NCT04334967 United States, Open label randomised controlled trial. Total Hospitalization [ Time Frame: 14 Enrolling by invitation; Medium
Vitamin C Oregon days ]
158
Version of 16.06.2020
N?1250 with COVID-19 randomised to Total Mechanical Ventilation [ Time Estimated Primary
hydroxychloroquine or vitamin C Frame: 14 days ] Completion:
September 30, 2021
Hydroxychloroquine ISRCTN86534580 UK multi- RCT Part of a Platform trial: Primary outcome measure Recruiting Medium
sulphate https://doi.org/10.1186/ centre, GP suspected coronavirus infection in Overall trial start date
ISRCTN86534580 practices, people aged 50 years and above with The need for hospital admission or 12/03/2020
sponsored by pre-existing conditions and those aged death, for patients aged ≥50 years with
Platform Randomised Office of the 65 years and above comorbidity, and aged ≥65 with or Overall trial end date
trial of INterventions Chief Medical Drug: Hydroxychloroquine without comorbidity and suspected 24/03/2021
against COVID-19 In Officer Comparator is usual care. COVID-19 infection during time of
older people (PRINCIPLE) (Government), prevalent COVID-19 infections,
led by Oxford measured by hospital admission or
NB. The ISRCTN registry University mortality related to suspected COVID-
is a primary clinical trial (Different study 19 within 28 days
registry recognised by from
WHO and ICMJE that NCT04303507)
accepts all clinical
research studies
(whether proposed,
ongoing or completed),
providing content
validation and curation
and the unique
identification number
necessary for
publication.
Hydroxychloroquine + NCT04335552 United States, a phase II, randomized, open-label, World Health Organization (WHO) Not yet recruiting; Medium
azithromycin North Carolina incomplete factorial with nested ordinal scale measured at 14 days after Estimated Primary
randomization clinical trial enrollment Completion Date
N=500 hospitalised patieNts with :August 1, 2020
COVID-19 randomised to
Standard of care alone
Standard of care plus
hydroxychloroquine
Standard of care plus azithromycin
Standard of care plus
hydroxychloroquine plus azithromycin
Hydroxychloroquine Eudract: 2020-001270- 3 EU An adaptive Phase 2/3, randomized, Phase 2: Change in SpO2/FiO2 ratio Ongoing Medium
29 memberstates open-label study assessing efficacy and from baseline to Day 15.
CZ (Ongoing) safety of hydroxychloroquine for Phase 3 (may be reassessed after
GB (Ongoing) hospitalized patients with moderate to review of phase 2): Change in
FR (Ongoing) severe COVID-19 SpO2/FiO2 ratio from baseline to Day
Denmark N=350 randomised to 15
hydroxychloroquine or standard of care
Chloroquine NCT04333628 Israel A Two Staged, Multicenter, Open Label change in the extent and duration of Not yet recruiting; Medium
and Randomized Trial virus shedding;
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Version of 16.06.2020
N= 210 participantsrandomised to change in the number of patients going Estimated Primary
Chloroquine regular dose from asymptomatic to moderately Completion: April
Chloroquine low dose disease 2021
placebo
Hydroxychloroquine vs NCT04329832 United States, A prospective Pragmatic randomised COVID Ordinal Outcomes Scale at 14 Not yet recruiting; Medium
Azithromycin Utah Trial. days [ Time Frame: Assessed once on Estimated Primary
N=300 hospitalised patients with day 14 after enrollment] Completion:
COVID-19 randomised to December 31, 2020
Hydroxychloroquine vs Azithromycin
Hydroxychloroquine NCT04330144 South korea Post exposure prophylaxis. The rate of COVID-19 Not yet recruiting; Medium
Open label randomised controlled trial. Estimated Primary
N=2486 participants exposed to SARS- Completion: March
CoV-2 30, 2021
Randomised to Hydroxychloroquine or
quarantine
Hydroxychloroquine NCT04330495 Spain Randomized, Controlled, Double-blind Incidence rate and prevalence of Not yet recruiting; Medium
Clinical Trial in patients with COVID-19 cases in both arms; Estimated Primary
inflammatory disease Under Biological Mortality rate; completion:
Treatment and / or JAK Inhibitors Intensive Care Unit admissions; November 6, 2020
N=800 randomised to
Hydroxychloroquine or placebo
Hydroxychloroquine + NCT04328272 Pakistan Open label randomised, placebo- National Early Warning Score equal to Not yet recruiting; Medium
Azithromycin controlled trial. zero [ Time Frame: 3-5 Days ] Estimated Primary
N= 75 patients with Mild to severe Completion; May 28,
COVID-19 randomised to 2020
Hydroxychloroquine,
Hydroxychloroquine + Azithromycin, or
placebo
Hydroxychloroquine + NCT04324463 Ontario, Canada Open-label, parallel group randomized Hospital Admission or Death Not yet recruiting: Medium
Azithromycin controlled trial Estimated Primary
Sponsor: Population N=1500 patients with COVID-19 Completion:
Health Research Institute randomised to Hydroxychloroquine + September 30, 2020
Azithromycin or standard of care
Hydroxychloroquine NCT04316377 University An Open Label Randomized Controlled Rate of decline in SARS-CoV-2 viral load Not yet recruiting; Medium
Sulfate Hospital, Pragmatic Trial [ Time Frame: Baseline (at Estimated Primary
Akershus, N=202 hospitalised patients with randomization) and at 96 hours ] Completion: April 1,
Norwey moderate to severe covid-19 2021
randomised to
hydroxychloroquine, or
placebo
Hydroxychloroquine + NCT04321278 Brazil, Open label randomised controlled trial . Clinical status o a 7-point scale [ Time Recruiting; Medium
azithromycin multicentres N=440 COVID-19 patients who require Frame: 15 days after randomization ]
oxygenation and/or ventilation Estimated Primary
Sponsor: Hospital Israelita randomised to Hydroxychloroquine + Completion: August
Albert Einstein azithromycin, or 30, 2020
160
Version of 16.06.2020
Hydroxychloroquine
Phosphoric Chloroquine ChiCTR2000029826 Hubei, China Randomised double blinded trial. Mortality rate Not yet recruiting. Medium
http://www.chictr.org.c Serious or critically ill patients From2020-02-17 To
Sponsor: n/showproj.aspx?proj=4 randomised to chloroquine (n=30) or 2020-03-17
Jingzhou Central Hospital 9481 placebo (n=15)
Chloroquine ChiCTR2000029837 Hubei, China A randomised, double-blind, parallel, Time of conversion to be negative of Not yet recruiting; Medium
http://www.chictr.org.c controlled trial novel coronavirus nucleic acid From2020-02-17 To
Sponsor: n/showproj.aspx?proj=4 Mild or moderate covid19 2020-03-17
Jingzhou Central Hospital 9495 Randomised to hydroxychloroquine
(n=80) or
Placebo (n=40)
Phosphoric chloroquine ChiCTR2000030031; Guangdong, A randomised, double-blind, parallel, Time of conversion to be negative of Recruiting; Medium
http://www.chictr.org.c China controlled trial novel coronavirus nucleic acid
The Sixth Affiliated n/showproj.aspx?proj=4 N=120 patients with mild and moderate From2020-02-20 To
Hospital of Guangzhou 9806 covid-19 randomised to phosphoric 2021-03-20
Medical University chloroquine (n=80) or placebo (n=40)
(Qingyuan People's
Hospital)
Hydroxychloroquine 2020-000890-25 France Single arm? Results of SARS-COV2 virus detection last visit of the last Medium
Non-commercial https://www.clinicaltrial Patients with documented respiratory (Day 1, Day 4, Day 7 and Day 14) participant.
sregister.eu/ctr- infection with coronavirus SARS COV 2
search/trial/2020- N=25
000890-25/FR#B
Hydroxychloroquine NCT04323631 Israel Open label randomised trial. Number patients developing severe Not yet recruiting; Medium
N= 1116 patients with mild to infection or death Estimated Primary
Sponsor: Rambam Health moderate COVID-19 Completion:
Care Campus December 2020
Hydroxychloroquine + NCT04322123 Brazil An Open-label, Randomized Controlled Clinical status of patients on the 15th Not yet recruiting; Medium
azithromycin Trial. day after randomization defined by the Estimated Primary
N=630 hospitalised patients with Ordinal Scale of 6 points. Completion: August
COVID-19 randomised to 30 2020
Hydroxychloroquine + azithromycin
Hydroxychloroquine, or
standard care
Hydroxychloroquine vs NCT04328961 New York and Post-expossure prophylaxis.Single Polymerase chain reaction (PCR) Not yet recruiting; Medium
Ascorbic Acid Washington blinded randomised controlled trial. confirmed SARS-CoV-2 infection day 14
N=2000 and day 28 Estimated Primary
Adults Exposed to Coronavirus Disease Completion;
randomised to Hydroxychloroquine vs September 30, 2020
Ascorbic Acid
Hydroxychloroquine NCT04331600 Not stated Multicenter, Randomized, Open-label COVID-19-related hospitalization or all- Not yet recruiting; Medium
Sponsor: Wroclaw Medical QUARANTINE2020 trial. cause death [ Time Frame: 15 days ] Estimated Primary
University N=400 ambulatory patients with COVID- Completion:
19 randomised to September 30, 2020
161
Version of 16.06.2020
hydroxychloroquine + telemedicine, or
telemedicine
Hydroxychloroquine Hydro-Stop-COVID19 IT, Ascoli Out-of-Hospital symptomatic confirmed Virologic clearance at day 8. Co-primary Not stated Medium
Trial Piceno. SARS-CoV-2 patients will be included in end-point: Hospital admission over the
Hydroxychloroquine + a pragmatic, randomized, open-label, time-interval between day 0 and day 15
SM vs. standard between-patient trial.
medications. 216 participants treated with either
https://www.aifa.gov.it/ hydroxychloroquine + SM vs. SM.
web/guest/-/covid-19- Treatment: Hydroxychloroquine 400 mg
aifa-autorizza-nuovo- loading dose the first day, followed by
studio-clinico-sull- 200 mg for 6 days + SM vs. standard
idrossiclorochina medications according to current
https://www.aifa.gov.it/ guidelines
documents/20142/1131 Inclusion criteria:
319/Hydro- 1. Patients with SARS-CoV-2 infection in
Stop_Documenti.zip a nasopharyngeal sample, with
diagnosis carried out in a centralized
core-lab.
2. Patients confined at home because
their clinical picture was judged by the
local Health authorities not severe
enough to require hospitalization.
3. Patients with 1 or more of the
following symptoms/signs on the day of
nasopharyngeal sample: 1) Fever
(>37.0° Celsius); 2) Dyspnea; 3) Cough.
Interim analysis will be performed on
the data from the first 50 patients
following two weeks of leronlimab
therapy.
Chloroquine Phosphate ChiCTR2000030718 China, Hubei, Open-label randomized parallel Time to Clinical Recovery Recruiting Medium
Wuhan controlled trial.
Sponsor: Study execute time:
Zhongnan Hospital of N=80 adult patients with confirmed 2020-02-12 to 2020-
Wuhan University COVID19 randomized 1:1 to 05-30
chloroquine phosphate or none (control
group).
Hydroxychloroquine and NCT04347889 Not stated Phase 2, open-label, randomized study COVID-19 Seroconversion rate [ Time Not yet recruiting Medium
vitamin C to evaluate prophylactic Frame: 3 months ]
hydroxychloroquine vs vitamin C. Estimated Study
Sponsor: Stony Brook Completion Date:
University N = 1212 healthcare workers at risk of December 30, 2020
Covid-19 randomized in a 2:1 ratio to
hydroxychloroquine or vitamin C
162
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Hydroxychloroquine + NCT04349592 Qatar Randomised, doubleblinded Proportion of virologically cured (no Not yet recruiting; Medium
Azithromycin placebocontrolled trial. virus detected) cases at day 6 [ Time Estimated Primary
N=456 patients with COVID-19 Frame: Day 6 ] Completion Date :
randomised to May 14, 2020
Hydroxychloroquine + Azithromycin,
Hydroxychloroquine + placebo, or
placebo + placebo
Hydroxychloroquine and NCT04361318 Egypt Phase 2/3, double-blind, randomized Number of patients with COVID-19- Not yet recruiting Medium
Nitazoxanide controlled parallel study evaluating negative PCR [ Time Frame: within 10
safety and efficacy of days to become PCR negative ] Estimated Primary
Sponsor: Hydroxychloroquine and Nitazoxanide Completion Date:
Tanta University combination as adjuvant therapy in October 2020
Covid-19 newly diagnosed Egyptian
patients.
N=200
163
Version of 16.06.2020
along with social distancing and
personal hygiene
Hydroxychloroquine NCT04384458 Brazil An open-blind, non-randomised trial to 1.Proportion of participants in whom Not yet recruiting Low
evaluate if hydroxychloroquine there was a clinical finding of COVID-19.
Sponsor: Nucleo De associated with zinc is effective as a [ Time Frame: Day 50 ] Estimated Primary
Pesquisa E prophylaxis compard standard care. 2.Symptomatic COVID-19 infections. [ Completion Date:
Desenvolvimento De Time Frame: Day 50 ] October 2020
Medicamentos Da N = 400 high-risk healthcare workers
Universidade Federal Do involved in suspected, or confirmed
Ceara cases of COVID-19
Hydroxychloroquine NCT04380818 Spain A non-randomized, open-label study to Efficacy of low-dose pulmonary Recruiting Low
Sulfate, evaluate the efficacy of low-dose lung irradiation assessed by change in PAFI
Ritonavir/lopinavir, irradiation as an adjunctive treatment O2 by 20% [ Time Frame: Day 2 after Estimated Primary
Tocilizumab, Azithromycin, in interstitial pneumonia interventional radiotherapy ] Completion Date: May
Corticosteroid, Low 4, 2021
molecular weight heparin, N = 106 patients with COVID-19
Oxygen supply, Radiation Comparative phase in two groups, a
control group, which will only receive
Sponsor: Grupo de pharmacological treatment, and an
Investigación Clínica en experimental one. It will include 96
Oncología Radioterapia patients, the allocation will be 1: 2, that
is, 32 in the control arm and 64 in the
experimental arm, which will receive
low-dose lung irradiation.
Hydroxychloroquine and NCT04365231 France A phase 3, randomized, open-label trial Percentage of patients with a negative Not yet recruiting Low
azithromycin to evaluate efficacy of RT-PCR test result to COVID-19 [ Time
hydroxychloroquine-azithromycin Frame: 7 days ] Estimated primay
Sponsor: Hospital St. treatment in preventing aggravation of Completion Date: June
Joseph, Marseille, France symptoms with development of 2020
hypoxemic respiratory failure and
complications of pregnancy.
N = 50 pregnant women
Hydroxychloroquine NCT04371926 United States? A randomized, single-blinded study to 1.Time to reach normal body Not yet recruiting Low
evaluate the prophylactic efficacy of temperature [Time Frame: 1 month ]
Sponsor: Texas Cardiac HCQ in COVID-19 cases compared to 2.Development of COVID-19 symptoms Estimated Study
Arrhythmia Research no-treatment. during HCQ preventive therapy in staff [ Completion Date: July
Foundation Time Frame: 1 month ] 2021
N = 64 patients with mild to moderate
symptoms and healthcare workers with
high exposure risk
Hydroxychloroquine EudraCT: 2020-001501- Italy Phase 2, open label, cluster-randomised 1. The proportion of subjects of Group 1 Not yet recruiting Low
24 trial evaluating the role of who become symptomatic and/or swab
Sponsor: Hydroxychloroquine versus observation positive in each arm within 1 month Estimated Primary
NCT04363827 only in preventing infection to COVID- from randomization. Completion Date
according to
164
Version of 16.06.2020
Istituto Scientifico PROTECT 19 or treating early phase COVID-19 2. The proportion of subjects of Group 2 clinicaltrials.org:
Romagnolo per lo Studio e patients who become swab negative in each arm September 2020
la cura dei Tumori within 14 days from randomization. According to protocol:
N=2000 COVID-19 index cases LP off treatment:
randomized 2:1 to hydroxychloroquine October 2020
or observation (arm A+B) + for each
COVID-19 index case, 1.5-2.0 healthy
subjects, cohabitants and/or contacts.
165
Version of 16.06.2020
Sponsor: HOSPITAL hydroxychloroquine. Those who refuse professionals with high risk of
UNIVERSITARI MÚTUA treatment will serve as control group transmission taking prophylaxis
TERRASSA (GroupA) and the control group of high
risk health professionals who decide not
to take it (Group C1) will be compared.
2. Incidence of symptomatic healthcare
professionals with positive PCR
between day 15 and day 30 of inclusion
in the study. Professionals with high risk
of transmission taking prophylaxis
(Group A) and the control
group of professionals with low risk of
transmission (Group C2) will be
compared.
Hydroxychloroquine and ChiCTR2000031376 China, Beijing Medical records based study to Safety and Effectiveness Recruiting Low
chloroquine determine the effect of
Hydroxychloroquine and chloroquine From 2020-03-28 To
Sponsor: Peking University 2020-05-29
Third Hospital N = 600 patients aged 18 to 75 years
with RT-PCR confirmed infection with
2019-nCoV
Hydroxychloroquine, NCT04351919 Tunisia Phase 4, Single Group Assignment, 1. improvment or healing of clinical Not yet recruiting Low
Azithromycin (multicenter) open-label trial on the efficacy and signs [ Time Frame: at the end of the
safety of hydroxychloroquine and study treatment - 1 month after Estimated Primary
Sponsor: azithromycin administrated to covid- inclusion ] Completion Date: July
Abderrahmane Mami 19(+) patients in Tunisia. 15, 2020
Hospital 2. Evolution of clinical signs [ Time
N=400 assigned to Hydroxychloroquine Frame: at the end of the study
(400mg per day during 10 days) + treatment - 1 month after inclusion ]
Azithromycin (500 mg per day during 5
days).
Hydroxychloroquine NCT04351620 United States, A phase I, single arm, open-label study 1.Tolerability of high dose HCQ as Recruiting Low
Illinois of high dose HCQ therapy in outpatient measured by HCQ dose modification.
Sponsor: University of adult participants with mild COVID-19. 2.Tolerability of high dose HCQ as Estimated Study
Chicago measured by discontinuation of HCQ Completion Date: June
N = 20 patients with COVID-19 who are 3. Tolerability of High Dose HCQ as 2020
not yet hospitalized, but have risk measured by Adverse Events
factors for disease progression and
complications.
Hydroxychloroquine, NCT04347798 Canada, Alberta Observational, Case-Control study 1.Impact of anti-malarials on the Enrolling by invitation Low
Chloroquine evaluating the impact of anti-malarial development and severity of Covid-19
drugs (eg. hydroxychloroquine and in the anti-malarial group compared to Estimated Primary
Sponsor: chloroquine) on the development of the non-anti-malarial group [ Time Completion Date:
University of Alberta COVID-19 compared to those patients Frame: 12 months ] April 2021
166
Version of 16.06.2020
who are not on anti-malarial drugs over
the next 6-12 months.
167
Version of 16.06.2020
followed by 3 weeks of weekly 400mg 30% as per CDC [Time Frame: 28 day
(2x 200mg tablets) by mouth. post enrollment]
Hydroxychloroquine NCT04345692 United States, Randomized, open label clinical trial. Clinical Status (on a 7-point ordinal Recruiting; Low
Sponsor: Hawaii N=350 patients randomized to scale) at day 15 Estimated Primary
Queen's Medical Centre hydroxychloroquine or usual care Completion;
December 31, 2021
UNIKINON (Chloroquine NCT04344951 Greece Phase 2, non-randomized, open label 50% reduction in symptom score for Recruiting Low
phosphate) clinical trial. patients with lower respiratory tract
HOPE infection [ Time Frame: Day 8 visit from Estimated Study
Sponsor: Uni-Pharma N = 60 patients with SARS-CoV-2 virus study initiation ] Completion Date:
Kleon Tsetis infection. April 30, 2021
Pharmaceutical Lack of progression for patients with
Laboratories S.A. upper respiratory tract infection [ Time
Frame: Day 8 visit from study initiation ]
Chloroquine NCT04345419 Egypt Open label randomized controlled trial Number of patients with decreased viral Not yet rectruiting; Low
Favipiravir N=100 patients with COVID-19 load [ Time Frame: 6 months ] Estimated Primary
Nitazoxanide randomised to Completion:
Ivermectin Chloroquine, December 2029?
Niclosamide Favipiravir,
Nitazoxanide,
Ivermectin, or
Niclosamide
Hydroxychloroquine, NCT04344457 United States, Open-label, single-arm study. Improvement of clinical status [ Time Recruiting Low
Indomethacin, Zithromax Arizona Frame: up to 28 days ]
Oral Product N=80 subjects positive with SARS-CoV-2 Measured by time (days) required from Estimated Primary
with mild symptoms. initiation of treatment to improvement Completion Date:
Sponsor: of clinical status from mild to symptom June 20, 2020
Perseverance Research Hydroxychloroquine (200 mg PO BID 5 free.
Center, LLC days)
Indomethacin (50 mg PO TID 14 Days)
Zithromax Oral Product (500 mg PO QD
3 Days)
Hydroxychloroquine 2020-001765-37 Spain Phase 2, open label, pragmatic clinical Percentage of patients (cohort A) and Ongoing Low
trial to evaluate the efficacy of professionals (cohort B) who achieve
Sponsor: Institut Català hydroxychloroquine in the treatment of control of the disease without Start date: 2020-04-11
d’Oncologia COVID-19 infection in two cohorts: symptoms in 14 days, assessed by chest
patients with oncohaematological radiography without pneumonia Estimate of duration:
disease and SARS-CoV-2 positive 4 months
without radiological alteration and sars-
cov-2 positive professionals without
radiological alteration.
168
Version of 16.06.2020
Nitazoxanide + NCT04341493 Mexico Randomized, single-blindede trial. Mechanical ventilation requirement [ Recruiting Low
hydroxychloroquine Time Frame: Since the diagnosis until
2020-03-681 N=86 COVID-19 patients with risk two weeks after ] Estimated Primary
Sponsor: Hugo Mendieta factors to get complicated: age more Percentage of patients COVID-19 Completion Date:
Zeron than 60 years old, diabetes mellitus or positive that required mechanical August 30, 2020
obesity grade II or more randomized to ventilation
Nitazoxanide + hydroxychloroquine or
Hydroxychloroquine
Hydroxychloroquine + NCT04341207 France Phase 2, non-randomized, open-label 1. Prevalence and the 3-months Recruiting Low
Azithromycin trial. incidence of SARS-CoV-2 in cancer
2020-001250-21 patients [ Time Frame: Up to 3 months ] Estimated Primary
Sponsor: Gustave Roussy, N=1000 advanced cancer patients Completion Date:
Cancer Campus, Grand devided into 4 cohorts. 2. Covid-19 disease-specific mortality April 2022
Paris rate in cancer patients treated by
SARS-CoV-2 positive test & Covid19 hydroxychloroquine and azithromycin [
symptoms: Hydroxychloroquine+ Time Frame: Up to 12 months ]
Azithromycin
169
Version of 16.06.2020
Hydroxychloroquine + NCT04335084 United States, An Open Label Phase II Pilot Study of Negative testing with RT-PCR [ Time Not yet recruiting; Low
azithromycin + vitamin C + California Hydroxychloroquine, Vitamin C, Vitamin Frame: 24 weeks ]
Vitamin D + Zinc D, and Zinc for the Prevention of Estimated Primary
COVID-19 Infection. Safety as determined by blood pressure Completion: April
N=600 health care workers exposed to readings [ Time Frame: 24 weeks ] 2021
SARS-CoV-2
Safety as determined by presence of
side effects [ Time Frame: 24 weeks ]
Hydroxychloroquine NCT04333225 United States, Randomised, open label trial. Rate of COVID-19 positive conversion Recruiting; Low
Texas N=360 health care workers exposed to on weekly nasopharyngeal (NP) Estimated Primary
SARS-CoV-2 randomised to sampling Completion: July 30,
hydroxychloroquine or no treatment 2020
Hydroxychloroquine + NCT04329572 Brazil Open, Multicentric, Non Randomized, Evolution of acute respiratory Not yet recruiting; Low
Azithromycin Exploratory Clinical Trial syndrome, oxygen saturation Estimated Primary
Single group assignment. Hospitalised hemodynamic stability [ Time Frame: 28 Completion: May 31,
patients will be treated with HCQ and days ] 2020
Azithromycin Update 06.05.2020:
suspended, the CRO
lost interest in the
study
Chloroquine phosphate NCT04328493 Hanoi, and Ho A Multi Center Randomized Open Label Viral clearance time [ Time Frame: Up Estimated Primary Low
Chi Minh City, Trial to 56 days post randomization ] Completion: April 1,
Vietnam N=250 hospitalised patients with 2021
COVID-19 stratified by study site and
severety of illness randomised to
chloroquine or standard care
Chloroquine vs ChiCTR2000029609 Guangdong, A prospective, open-label, multiple- Primary Outcome(s) From2020-02-10 To Low
liponavir/ritonavir China center study or patients with Covid-19 virus nucleic acid negative-transforming 2020-12-31
http://www.chictr.org.c stratified by severity. time;
n/showproj.aspx?proj=4
9145 Mild symptoms randomised to
chloroquine phosphate (n=59)
lopinavir/ritonavir (59), or
Chloroquine + lopinavir/ritonavir (59)
170
Version of 16.06.2020
http://www.chictr.org.c Randomised to hydroxychloroquine 0.2
n/showproj.aspx?proj=4 mg bid (n=52), or
9317 conventional therapy (n=24)
Chloroquine ChiCTR2000029939 Zhejiang, China Single-blind, Randomised, Controlled Length of hospital stay Recruiting; Low
http://www.chictr.org.c Clinical Trial From2020-02-06 To
n/showproj.aspx?proj=4 2021-02-06
9612 N=100 patients with covid-19 (severity
unknown), randomised to chloroquine
phosphate or placebo
Chloroquine ChiCTR2000029935 Zhejiang, China Single arm study, N=100 patients with Length of hospital stay Recruiting; Low
http://www.chictr.org.c covid-19 (severity unknown), treated From2020-02-06 To
n/showproj.aspx?proj=4 with chloroquine phosphate 2021-02-06
9607
Hydroxychloroquine ChiCTR2000029899 Hubei, China Randomised, Open-label, Parallel, Time to clinical recovery (time frame 28 Recruiting; Low
sulfate vs phosphate http://www.chictr.org.c Controlled Trial days) From2020-02-17 To
chloroquine n/showproj.aspx?proj=4 N=100 with mild or moderate covid-19 2020-04-30
9536 randomised to Hydroxychloroquine
sulfate, or phosphate chloroquine
Hydroxychloroquine ChiCTR2000029898 Hubei, China Randomised, Open-label, Parallel, Time to clinical improvement (time Recruiting; Low
sulfate vs phosphate http://www.chictr.org.c Controlled Trial frame 28 days) From2020-02-17 To
chloroquine n/showproj.aspx?proj=4 N=100 with severe covid-19 2020-04-30
9482 randomised to Hydroxychloroquine
sulfate, or phosphate chloroquine
Hydroxychloroquine ChiCTR2000029992 Hubei, China Randomised, Open-label, Parallel, Clinical recovery time (6-point scale); Not yet recruiting; Low
sulfate vs phosphate http://www.chictr.org.c Controlled Trial Changes in viral load of upper and lower From2020-02-17 To
chloroquine n/showproj.aspx?proj=4 N=100 with severe covid-19 respiratory tract 2020-05-20
9574 randomised to
Hydroxychloroquine sulfate (n=40), or
phosphate chloroquine (n=40), or
routine treatment (n=20)
Chloroquine phosphate ChiCTR2000029988 Hubei, China Open label clinical trial. Time to clinical recovery Recruiting; Low
http://www.chictr.org.c N=80 patients with severe covid-19
n/showproj.aspx?proj=4 randomised to chloroquine phosphate From2020-02-13 To
9218 or no treatment 2020-05-31
Chloroquine phosphate ChiCTR2000029975 Jilin, China Single arm study of 10 patients; severity Viral negative-transforming time; Not yet recruiting; Low
aerosol inhalation http://www.chictr.org.c is not defined. 30-day cause-specific mortality
n/showproj.aspx?proj=4 From2020-02-24 To
9592 2020-05-31
Hydroxychloroquine ChiCTR2000030054 Hubei, China Randomised, Open-label, Parallel, Clinical recovery time, time frame 28 Not yet recruiting; Low
sulfate vs chloroquine http://www.chictr.org.c Controlled Trial days From2020-02-17 To
phosphate n/showproj.aspx?proj=4 N=100 with mild or moderate covid-19 2020-05-21
9869 randomised to
Hydroxychloroquine sulfate (n=40), or
phosphate chloroquine (n=40), or
routine treatment (n=20)
171
Version of 16.06.2020
Chloroquine ChiCTR2000029803 Hubei, China Prevention. Number of patients who have Not yet recruiting; Low
http://www.chictr.org.c Prospective, randomised, open-label, progressed to suspected or confirmed From2020-02-20 To
n/showproj.aspx?proj=4 controlled clinical study to evaluate the within 24 days of exposure to new 2021-02-20
9428 preventive effect of coronavirus
hydroxychloroquine on close contacts
after exposure (COVID-19)
320 patients randomised to
hydroxychloroquine small dose, high
dose, abidol small dose or abidol high
dose.
Chloroquine phosphate ChiCTR2000030417 Heilongjiang, Randomised controlled trial. N=30 Several primary outcomes: Temerature, Not yet recruiting Low
inhalation http://www.chictr.org.c China patients with covid-19 randomised to respiratory symptoms improvement, From2020-03-01 To
n/showproj.aspx?proj=5 chloroquine phosphate aerosol pulmonary imaging improvement, 2020-06-30
0279 inhalation or water for injection negative virus test
atomization inhalation
Chloroquine ChiCTR2000029542 Guangdong, Phase 4, open label, non-randomised Viral negative-transforming time, 30- Recruiting Low
China day cause specific mortality
http://www.chictr.org.c N=20 with covid-19 From2020-02-03 To
n/showproj.aspx?proj=4 Treatment: chloroquine or conventional 2020-07-30
8968 treatment
Hydroxychloroquine + NCT04326725 Turkey Proflaxis for Healthcare Professionals No infection within 4 months Recruiting; Low
Vitamins A, C, D and Zinc Using Hydroxychloroquine Plus Vitamin Estimated Primary
Combining Vitamins A, C, D and Zinc Completion: July 1,
During COVID-19 Pandemia: An 2020
Observational Study
Hydroxychloroquine in NCT04374903 Jordan A pilot, multicenter randomized open- Time to Clinical improvement (TTCI) [ Not yet recruiting Low
combination with label trial to evaluate Time Frame: 28 Days ]
azithromycin or sirolimus hydroxychloroquine in combination Estimated Study
with azithromycin or sirolimus for Completion Date:
Sponsor: King Hussein treating COVID-19 patients September 1, 2020
Cancer Center
N = 58
Hydroxychloroquine (HCQ) NCT04384380 Taiwan Phase 4, multi-center, randomized, Time to negatively RT-PCR [ Time Recruiting Low
open-label, controlled trial to evaluate Frame: 14 days ]
Sponsor: the efficacy and tolerability of HCQ in Estimated Primary
Taoyuan General Hospital adult patients with mild to moderate Completion Date: June
COVID-19 vs. standard of care. 30, 2020
172
Version of 16.06.2020
Henri Mondor insurance database (SNDS) and the
French national hospital discharge
Créteil, France, database (Programme de
94000 Médicalisation des Systèmes
d'Information, PMSI)
Hydroxychloroquine ChiCTR2000029760 Chongqing Randomised controlled study Time to clinical recovery Cancelled due to lack Low
http://www.chictr.org.c N=240 Patients with mild or moderate of patients
n/showproj.aspx?proj=4 infectious disease
9369
Chloroquine ChiCTR2000029762 Chongqing, 60 patients with severe covid-19 Negative conversion rate of COVID-19 Cancelled due to lack Low
China nucleic acid of patients
http://www.chictr.org.c
n/showproj.aspx?proj=4 Lung inflammation absorption ratio
9404
Chloroquine ChiCTR2000029761 Chongqing, 240 patients randomised to 3 different Negative conversion rate of 2019-nCoV Cancelled due to lack Low
China doses of hydroxychloroquine or nucleic acid of patients
http://www.chictr.org.c conventional treatment
n/showproj.aspx?proj=4 Lung inflammation absorption ratio
9400
NCT04389567 United States, Observational retrospective, case-only Symptomatic improvement [Time Active, not recruiting Low
Famotidine New York study on Famotidine Use in Non- Frame: 2 weeks]
hospitalized Patients With COVID-19 Estimated Primary
Sponsor: Northwell Health Completion Date: May
20, 2020
173
Version of 16.06.2020
N = 10, with confirmed Covid-19
infection using Famotidine during
illness
NCT04371978 Not stated Phase 3, randomized, open-label to Time to clinical change [ Time Frame: 28 Not yet recruiting Medium
Linagliptin evaluate the efficacy and safety of days ]
Dipeptidyl Peptidase-4 Inhibitors Estimated Study
Sponsor: (Linagliptin) in diabetic patients with Completion Date:
Rabin Medical Center established COVID-19 September 30, 2021
174
Version of 16.06.2020
NCT04363372 Not stated A phase 2, randomised, double-blind, Change in mean clinical status score in Not yet recruiting Medium
MRx-4DP0004 placebo controlled study to evaluate each treatment arm [ Time Frame:
the efficacy and safety of MRx- Baseline to Day 42 ] Estimated primary
A Bifidobacterium breve 4DP0004. Completion Date:
strain isolated from the August 2020
microbiome of a healthy N = 90 hospitalised patients will be
human infant enrolled and randomised (2:1) to
receive MRx-4DP0004 or placebo
Sponsor: 4D pharma plc
NCT04395716 United States, Phase 1 open-label interventional study 1.The rate of recovery of mild or Not yet recruiting Low
ResCure California which will test the efficacy of ResCure™ moderate COVID-19 in patients using
in the treatment of patients with ResCure™ [Time Frame: 12 Weeks] Estimated Primary
COVID-19 infection. Completion Date: May
Sponsor: ProgenaBiome 2.Reduction or progression of 2021
N = 50 patients age < 18 with severe symptomatic days [Time Frame: 12
respiratory symptoms that are at or Weeks]
near requiring the patient be placed on
a ventilator to recieve nebullized
ResCure™ while hospitalized every 4 to
6 hours.
Probiotics ChiCTR2000029974 Shandong, A prospective, multicenter, open-label, Time to Clinical recovery Recruiting; Low
http://www.chictr.org.c China randomised, parallel-controlled trial.
n/showproj.aspx?proj=4 N=300 patients with mild to severe From2020-02-09 To
9321 covid-19 randomised to live Clostridium 2020-08-31
Butyricum Capsules and Live Bacillus
Coagulans Tablets for 14 days
Lactobacillus coryniformis NCT04366180 Spain A randomized, double-blind, placebo- Incidence of SARS CoV-2 infection in Recruiting Medium
K8 (probiotic) controlled study to evaluate the effects healthcare workers [ Time Frame: 8
of Lactobacillus coryniformis K8 weeks ] Estimated Study
Sponsor: Biosearch S.A. consumption on the incidence and Completion Date:
severity of Covid-19 in health workers October 2020
exposed to the virus
N = 40
175
Version of 16.06.2020
NCT04365517 Italy Phase 3, randomized, controlled, open 1. Time for clinical improvement [ Time Not yet recruiting Low
Sitagliptin label trial to evaluate the effect of Frame: 1 month ]
Sitagliptin treatment in COVID-19 2. Clinical parameter of acute lung Estimated primary
Sponsor: positive diabetic patients. disease [ Time Frame: 1 month ] Completion Date: May
University of Milan 3. Biochemical parameter of acute lung 30, 2020
N=170 type 2 diabetes, covid-19 disease [ Time Frame: 1 month ]
positive randomized to Sitagliptin +
nutritional therapy with/without insulin
treatment or nutritional therapy
with/without insulin treatment.
Vitamins and NCT04401150 Canada Phase 3 randomized, blinded, placebo Death or persistent organ dysfunction [ Not yet recruiting High
controlled trial. Time Frame: Both assessed at 28 days ]
minerals Number of deceased participants or Estimated Primary
Intravenous vitamin C administered in with persistant organ dysfunction Completion Date:
Vitamin C bolus doses of 50 mg/kg mixed in a 50- (dependency on mechanical ventilation, November 2021
ml solution of either normal saline new renal replacement therapy, or
Sponsor: Université de (0.9% NaCl) or dextrose 5% in water vasopressors).
Sherbrooke (D5W) during 30 to 60 minutes, every 6
hours for 96 hours (i.e. 200 mg/kg/day
and 16 doses in total).
176
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Sponsor: National Institute 2. Length of hospital stay [Time
of Integrative Medicine, N = 200 with Covid-19 randomised to Frame: at 15 and 45 days since
Australia Hydroxychloroquine, Azithromycin, admission/ enrolment]
Zinc, Vitamin D and Vitamin B12 With 3. Invasive mechanical ventilation or
or Without Vitamin C mortality [Time Frame: any time
within 15 days from enrolment]
Vitamin C 0.5 g + ChiCTR2000029768 Hubei, China A randomised, open, controlled trial Time to Clinical recovery Recruiting; Low
diammonium http://www.chictr.org.c N=60 patients with covid-19 From2020-02-12至To
glycerrhizinate enteric n/showproj.aspx?proj=4 2020-05-12
coated capsules 150 mg 9131
t.i.d.
Vitamin C ChiCTR2000029957 Shaanxi and Case series, observational study of 56 Ventilation-free days; Not yet recruiting; Low
http://www.chictr.org.c Hubei, China patients with severe or critical covid-19 mortality; From2020-02-24 To
n/showproj.aspx?proj=4 2021-02-28
9633
Vitamin C ChiCTR2000030135 Hubei and Randomised trial, Blinding not stated; Ventilation free days; Not yet recruiting; Low
Shaanxi, China Severe or critical covid-19 patients Mortality From2020-02-25 To
http://www.chictr.org.c High dose vitamin: N=26 2021-02-28
n/showproj.aspx?proj=5 Routine treatment: N=13
0002
Vitamin C (L-ascorbic acid) NCT04357782 United States, Phase 1/2, open-label, non-randomized Incidence of adverse events and Recruiting Low
Virginia trial on the use of Intravenous Vitamin reactions [Time Frame: Days 1-4]
Sponsor: Hunter Holmes C and Decreased Oxygenation Estimated Study
Mcguire Veteran Affairs Completion Date:
Medical Center N = 20, age ≥ 18, hospitalized with August 1, 2020
Covid-19 infection
Vitamin C (L-Ascorbic Acid) NCT04344184 United States, Phase 2, randomized, blinded trial on Number of ventilator-free days [ Time Not yet recruiting Medium
Virginia patients with hypoxemia and suspected Frame: Up to 28 days ]
Sponsor: EVICT-CORONA-ALI COVID-19 will reduce the lung injury Estimated Primary
Virginia Commonwealth caused by the SARS-Cov-2. Completion Date:
University April 2021
N=200 randomized to vitamin C (100
mg/kg intravenous infusion every 8
hours for up to 72 hours) or placebo
Vitamin C ChiCTR2000032400 China, Shanghai A prospective, randomized, controlled - C-reactive protein [0, 3, 7 days after Recruiting Low
trial to evaluate the efficacy and safety admission]
Sponsor: Rujin Hospital, of high dose intravenous vitamin C in From 2020-01-01 To
Shanghai Jiao Tong the treatment of novel coronavirus - ESR [0, 3, 7 days after admission] 2020-06-01
University School of pneumonia (COVID-19).
Medicine Blinding not stated. - Existence of SIRS [0, 3, 7 days after
admission]
N=120 randomized to High dose
intravenous vitamin C or normal saline
(control group).
Vitamin C intravenous NCT04323514 Italy Single arm, open label. In-hospital mortality Recruiting; Low
N=500 patients with COVID-19
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Estimated Primary
Completion: March
2021
Ascorbic Acid (vitamin C), NCT04342728 United States, Randomized, open-label, prospective, Symptom Reduction [ Time Frame: 28 Enrolling by invitation Low
Zinc Gluconate Ohio four arm, single-center study. days ]
Sponsor: The Cleveland COVIDAtoZ Estimated Primary
Clinic Single Group Assignment Completion Date:
September 30, 2020
N=520, age > 18 who present to the
Cleveland Clinic outpatient testing and
receive a positive test for COVID-19 will
be invited to participate.
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order to determine the relationship Estimated Primary
between baseline vitamin D deficiency Completion Date:
and clinical characteristics August 2020
N = 64
Vitamin D3 NCT04407286 United States Phase 1 open-label signle group. Vitamin D levels [ Time Frame: baseline Recruiting Low
and after two weeks of vitamin D
Sponsor: Arizona State N=100 adults with previous confirmed supplementation ] Estimated Primary
University COVID-19 with low levels of Vitamin D Completion Date:
to receive supplementation. Severity of COVID 19 symptoms [ Time August 18, 2020
Frame: baseline and at 2 weeks after
vitamin D supplementation ]
Cholecalciferol 2020-002312-43 Spain Phase 3, randomized, open-label study Increased levels of 25-hydroxyvitamin Ongoing Low
to evaluate the efficacy of D3 will be determined on days 7,
Sponsor: administering high-dose cholecalciferol and 14 after initiation of treatment Estimated primary
Miguel Cervero Jiménez, orally alongside standard therapy in completion date: Not
servicio de Medicina patients with COVID-19 pneumonia stated
Interna, Hospital (COVID-19 HUSO).
Universitario Severo
Ochoa N=82
Cholecalciferol NCT04411446 Argentina Phase 4, randomized, controlled, 1. Respiratory SOFA. [ Time Frame: One Not yet recruiting Medium
double-blind clinical trial comparing a week ]
Sponsor: CARED 500.000 UI dose of vitamin D versus Estimated Primary
Vitamin D Study Group placebo among COVID-19 patients at 2. Need of a high dose of oxygen or Completion Date:
moderate risk, requiring hospitalization mechanical ventilation. [ Time Frame: December 15, 2020
but without requirements of critical 30 days ]
care at admission.
N=1265
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Sponsor: Tehran University investigate the therapeutic efficacy of 2.Severity of COVID-19 (SARA-Cov-2) Estimated Primary
of Medical Sciences rapidly correcting vitamin D deficiency infection [ Time Frame: 60 days ] Completion Date:
in adults with the use of 25- 3.Hospitalization [ Time Frame: 60 days November 15, 2020
hydroxyvitamin D3 [25(OH)D3] for ]
reducing the risk of acquiring the SARS- 4.Disease duration [ Time Frame: 60
CoV-2 (COVID-19) viral infection and days ]
mitigating morbidity and mortality 5.Death [ Time Frame: 60 days ]
associated with this infection. 6.Oxygen support [ Time Frame: 60 days
N = 1500 subjects in 3 study groups that ]
include hospital health providers,
patients with a positive test for COVID-
19 and their relatives with a negative
test.
Vitamin D 2020-002274-28 Spain Phase 4, randomized, 2-armed trial to - Percentage and time of patients who Ongoing Low
evaluate the likely beneficial effects of have a negative SARS-CoV-2 viral load
Sponsor: vitamin D on infection with coronavirus - Clinical symptoms and time during Estimated Primary
Fundación para la hospitalization Completion Date:
Investigación y la N=60 adult subjects with covid-19 - Improvement of biochemical and 2020-09-21
Innovación Biosanitaria del treated ind the ER og admitted to the molecular parameters of inflammation
Principado de Asturias hospital randomized to vitamin D - Overall mean hospital stay
(FINBA) (single dose of native vitamin D - Percentage of patients requiring
(100,000 IU of Colecalciferol) or a transfer to the ICU
comparator, which is not stated - Average stay in ICU
- Mortality during follow-up
[Time frame: 14 and 21 days or until a
negative SARS-CoV-2 test every 7 days]
Calcifediol 2020-001717-20 Spain (multiple Phase 2, randomized, controlled, open- 1) Admission to the Intensive Care Unit Ongoing Low
sites) label trial. or
Sponsor: NCT04366908 2) Death Estimated duration of
Fundación para la N=1005 subjects ≥ 18 and <90 years, 1) Ingreso en Unidad de Cuidados the trial: 5 months
Investigación Biomédica positive covid-19 randomized 1:1 to intensivos o Estimated primary
de Córdoba calcifediol p.o. or best available 2) Fallecimiento completion: July 28,
treatment. [Time frame: Daily throughout the 2020
subject duration in the trial.]
Zinc and Vitamin D3 NCT04351490 France? A randomized, open-label study to Survival rate in asymptomatic subjects Not yet recruiting Low
evaluate impact of Zinc and Vitamin D3 at inclusion [ Time Frame: Two months
Sponsor: University (ZnD3-CoVici) supplementation on the survival of after inclusion ] Estimated Study
Hospital, Lille institutionalized aged patients infected Completion Date: July
with COVID-19 2020
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From2020-03-02 To
2020-04-30
Zink i.v. Australia New Zealand Australia RCT COVID-19 symptomatic confirmed Not yet recruiting Medium
ACTRN12620000454976 Lead center: i.v. high dose zink vs. placebo hospitalized adult patients.
Department of In non-ventilated patients- Primary
Surgery Patients will be allocated in a 1:1 ratio outcome:
University of to either the treatment group receiving Mean change in the worst (highest)
Melbourne, intravenous zinc chloride (0.5mg/kg/d) level of oxygenation (oxygen flow in
Austin Health or to control group, receiving saline litres/min). This will be assessed by the
Heidelberg, VIC placebo alone nursing documentation in the
3084 participant's electronic record of the
flow rate of oxygen delivered and the
delivery method (ie nasal prongs,
Hudson mask, or non-breather mask).
In ventilated patients- Mean change in
the worst (lowest) PaO2 /FiO2 ratio (in
mmHg). This will be assessed by nursing
documented PaO2 and FiO2 levels in
the patient chart. Worst recorded level
of oxygenation during the 7 days of
intervention.
Mortality 28 days
Oral nutrition supplement NCT04323228 Saudi Arabia Double-blinded, randomised controlled Several primary outcomes: Not yet recruiting; Low
(ONS) enriched in trial. Nutrition risk screening, serum ferritin, Estimated Primary
eicosapentaenoic acid, N=30 randomised to IL-6, CRP, TNFa, MCP-1 r Completion: October,
gamma-linolenic acid and enriched ONS or 2020
antioxidants isocaloric/isonutrigenous ONS
Eicosapentaenoic acid NCT04335032 Not stated Single group assignment. Time to treatment failure during the 28- Not yet recruiting; Low
N=240 treated with Eicosapentaenoic day treatment period. Estimated Primary
Acid Completion: July 13,
2020
Icosapent Ethyl NCT04412018 Canada, Ontario Phase 2, prospective, multi-site, two- 1. Change in hs-CRP levels from the Recruiting Low
(VascepaTM) armed, randomized, open-label study to randomization visit (Day 1) to the Day
evaluate the Effects of Icosapent Ethyl 14 visit [ Time Frame: 14 days ] Estimated Primary
Sponsor: (VascepaTM) on Inflammatory Completion Date:
Canadian Medical and Biomarkers in Individuals With COVID- December 2020
Surgical Knowledge 19.
Translation Research
Group N=100 outpatients in Canada who have
received a positive SARS-CoV-2 test
result within the preceding 72 hours,
randomized 1:1 to icosapent ethyl (4 g
BID for 3 days, then 2 g BID for the
subsequent 11 days) or usual care.
L-citrulline NCT04404426 France Prospective, multicenter, placebo- SOFA [ Time Frame: Day 7 ] Not yet recruiting Medium
controlled, randomized, double-blind
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Sponsor: CACOLAC study of Citrulline Administration in the Estimated Primary
Rennes University Hospital Hospital Patient in Intensive Care for Completion Date: June
COVID-19 Acute Respiratory Distress 15, 2021
Syndrome
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Oseltamivir 150 mg /12 h for 5 days,
Azithromycin 1 gm first day then 500
mg/day for 1st line or Clarithromycin
500 mg/12 h for 7-14 days, Ascorbic
acid 500 mg/12 h and Cyanocobalamin
IV once daily plus Lopinavir
400mg/Ritonavir 100 mg caps 2
capsules twice daily in severe cases.
Isotretnoin, Tamoxifen NCT04389580 Egypt Phase 2, open-label, randomized trial Lung injury score [Time Frame: at 7 Not yet recruiting Medium
on Combination Therapy With days]
Sponsor: Kafrelsheikh Isotretinoin and Tamoxifen as Estimated Primary
University Protection Against Severe Acute Completion: July 2020
Respiratory Syndrome
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NCT04304313 Hubei, China Phase 3, pilot study, single arm study Rate of disease remission Recruiting; Low
Sildenafil N=10 Rate of entering the critical stage Estimated primary
Time of entering the critical stage completion:
Time frame 14 days 01.03.2020
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Sponsor: N=240 patients with COVID-19 Estimated Primary
Nadační fond Donatio AZIQUINE-ICU admitted to ICU randomized to Completion:
intensivistam azithromycin + hydroxychloroquine, December 31, 2021
Hydroxychloroquine + placebo, or
Placebo
Azithromycin with NCT04363060 France A phase 3, randomized, open label Rate of positive SARS-CoV-2 RT-PCR [ Not yet recruiting Medium
amoxicillin/clavulanate controlled trial to evaluate Time Frame: Day 6 ]
Azithromycin With Estimated Study
Sponsor: Nantes University Amoxicillin/Clavulanate versus Completion Date: July
Hospital Amoxicillin/Clavulanate Alone. 30, 2020
N = 64
Azithromycin + NCT04336332 United States, Open label randomized controlled trial. Changes in patients viral load [ Time Recruiting; Low
Hydroxychloroquine vs New Jersey N=160 with confirmed COVID-19 Frame: Baseline, day 3 and day 6 ] Estimated Primary
hydroxychloroquine randomised to azithromycin + Completion: April 30,
hydroxychloroquine sulfate, or 2021
Hydroxychloroquine sulfate, or
Standard of care
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Atovaquone/Azithromycin NCT04339426 Not stated Open-label, non-randomized single arm Virology Cure Rate [ Time Frame: 10 Recruiting; Low
Sponsor: study. days ] Estimated Primary
HonorHealth Research N=25 assigned to Completion; October
Institute Atovaquone+azithromycin 2020
NCT04398004 Greece A phase 2, open-label non-randomized 1.Clinical outcome negative for two Recruiting Low
Clarithromycin clinical trial of anti-inflammatory parameters(hospital admission/disease
(ACHIEVE) Clarithromycin to improve SARS-CoV-2 progression) [ Time Frame: Day 1 to Day Estimated Primary
Sponsor: Hellenic Institute (COVID-19) infection 8] Completion Date: May
for the Study of Sepsis 2.At least 50% change of the score of 6, 2022
N = 90 respiratory symptoms from the baseline
[ Time Frame: Day 1 to Day 8 ]
NCT04371952 France A phase 3 randomized, double-blind, 1.Clinical worsening SaO2 [ Time Frame: Not yet recruiting Medium
Doxycycline placebo-controlled study to compare a after at least 48 hours of treatment ]
(DYNAMIC) treatment with doxycycline vs a 2.Patients hospitalized [ Time Frame: Estimated Study
Sponsor: Nantes University placebo. after at least 48 hours of experimental Completion Date:
Hospital treatment ] December 1, 2020
N = 330 patients without hospitalization 3.Ventilatory assistance [ Time Frame:
criteria Day 0 to Day 28 ]
2020-001243-15 Belgium Randomised, open label trial. Clinical status of subject at day 15 (on a Ongoing Medium
Itraconazole N= 200 hospitalized patients 7-point ordinal scale)
Sponsor: UZLeuven randomized to itraconazole or standard
of care
ChiCTR2000032242 China, A multicenter, randomized, open-label, - Virus negative time Not yet recruiting Medium
Kolimycin Heilongjiang controlled trial for the efficacy and
safety of oral kolimycin in the - Medication 3, 5, 7, 9, 11, 13, 15 days From 2020-04-24 To
Used for the treatment of treatment of patients with new mouthwash (pharyngeal swab) 2019- 2021-05-01
infections in Japan and coronavirus pneumonia (CoVID-19) nCOVRNA negative rate (%)
Turkey
Sponsor: Mudanjiang N=350 randomized 1:1 to basic
Kang'an Hospital treatment + kolimycin or basic
treatment (control group).
Nervous system
Product Study identifier Study location Study design Primary outcome Status of trial Importance
Chloropromazine NCT04354805 Egypt Phase I/II, randomized, blinded trial to Lactate dehydrogenase (LDH) [ Time Not yet recruiting Low
evaluate the effect of administration of Frame: 2 weeks ]
the Chlorpromazine on COVID-19 LDH is an enzyme indicate some form of Estimated Primary
Sponsor:
patients. tissue damage, Normal LDH levels range Completion Date:
Cairo University
from 140 units per litre (U/L) to 280 August 2020
N=60 COVID-19 adult patients U/L.
randomized 1:1 to Chlorpromazine (25
mg every 6 hours for 1 week) in
addition to the conventional treatment
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of COVID-19 or conventional treatment
of COVID-19 only
Chlorpromazine NCT04366739 France A phase 3, randomized, single-blind, Time To Response (TTR) [ Time Frame: Not yet recruiting Low
pilot clinical study to explore the 28 days ]
Sponsor: Centre (reCoVery) efficacy and safety of chlorpromazine The primary endpoint is the time to Estimated Study
Hospitalier St Anne (CPZ) in the treatment of COVID-19 response (TTR) in days, from Completion Date:
compared to standard of care. randomization to 28th day. By response August 30, 2020
to treatment is meant the reduction of
N = 40 adult subjects with COVID-19- at least one severity level on the World
moderate type (WHO-OSCI 3-5). Health Organization Ordinal Scale for
Clinical Improvement (WHO-OSCI)
1,3,7- NCT04395742 France Observational, controlled, retrospective Comparison of vital status [Time Frame: Not yet recruiting Low
study on 1,3,7-Trimethylxanthine as a 6 days]
Trimethylxanthine Treatment of COVID-19 Estimated Primary
Completion Date:
(caffeine) N = 93, hospitalized with Covid-19 December 2020
receiving either coffee with 1,3,7-
Sponsor: Poitiers trimethylxanthine or tea and hot
University Hospital chocolate with milk
NCT04358627 Not stated Observational, case-control study to Mechanical ventilation [ Time Frame: Not yet recruiting Low
Dexmedeto- evaluate the impact of expected within first three days (non
midine dexmedetomidine infusion on conclusive due to lack of evidence yet) ] Estimated primary
improving the outcomes of ARDS Completion Date: May
compared to control (no DEX). 30, 2020
Sponsor: Hospital Clinic of
Barcelona
N = 80 patients admitted to critical care
because of signs of respiratory
insufficiency requiring non-invasive
ventilation
Fluvoxamine NCT04342663 United Sates, Phase 2, double-blinded, placebo- Time to clinical worsening [ Time Recruiting Medium
Illinois, Missouri controlled clinical trial of Fluvoxamine Frame: RCT (approximately 15 days) ]
(STOP COVID) for Symptomatic Individuals with Estimated primary
Sponsor: Washington COVID-19 Completion Date: June
University School of 1, 2020
Medicine N=152, infected with COVID-19 with
current mild symptoms
187
Version of 16.06.2020
[Time freame: 16 weeks] Estimated Primary
Completion: April
2021
NCT04374032 Bosnia and Phase 2/3, open-label, randomized trial Time to onset of change in the patient's Recruting Medium
Metenkefalin + Herzegovina on the Efficacy and Safety of an clinical condition
Tridecactide Immunomodulatory Therapy (Enkorten) Estimated Study
for the Treatment of Patients With Safety and tolerability evaluation - Completion Date:
Moderate to Severe COVID-19 Infection treatment-related adverse events will October 31, 2020
Sponsor: Bosnalijek D.D be assessed by CTCAE
N = 120, hospitalised with moderate to
severe COVID-19 infection and [Time Frame: 21 days]
pneumonia randomized to
metenkefalin + tridecactide or standard
of care
NCT04365985 United States, Phase 2, prospective, single center, Progression of oxygenation needs [ Not yet recruiting Medium
Naltrexone and Michigan randomized, double blinded study of Time Frame: up to 1 month ]
Ketamine SINK COVID-19 naltrexone with an open label extension Estimated Primary
using ketamine as a rescue drug for completion: May 2020
patients who progress in their disease.
Sponsor:
William Beaumont
N=500 subjects age ≥18, positive for
Hospitals
COVID-19 randomized to Naltrexone or
placebo.
The use of ketamine will be unblinded
and given as a rescue agent for patients
who progress in their disease
NCT04343963 Mexico Randomised doubled blinded trial Critical condition or death [ Time Recruiting; Medium
Pyridostigmin 436 participants hospitalized with Frame: 28 days ] Estimated Primary
covid-19 randomised to pyridostigmine Completion:
or placebo. September 30, 2020
NCT04355962 Switzerland Randomised, double-blinded controlled Composite outcome of death rate (rate Recruiting; Medium
Sevoflurane trial. of patients that did not survive) and Estimated Primary
(SevCov) N=64 patients with COVID-19 organ failure rate (rate of patients Completion: March
Sponsor: randomised to sevoflurane or other surviving with persistent organ 31, 2021
University of Zurich sedatives e.g. propofol, fentanyl, dysfunction) at day 28 [ Time Frame: 28
midazolam or dexmedetomidine days ]
EudraCT: 2020-001618- Barcelona, Open-label, randomized, multicenter Number of patients requiring Recruiting Medium
Vafidemstat, 39, Spain (3), double-arm Phase II trial. mechanical ventilation and referral to
CNS optimized LSD1 “ESCAPE” ICU from day 1 to day 14 Estimated duration of
inhibitor N=40 randomized to vafidemstat or the trial: 28 days
standard of care (e.g., chloroquine, Global mortality from day 1 to day 14
Sponsor: Oryzon lopinavir/ritonavir, azithromycin, or any
Genomics, S.A. other being applied by the Hospitals
according to the current guides).
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type to receive artemisinin-pipequine
tablets.
Ivermectine + NCT04343092 Not stated Phase 1, double-blinded, randomized, Number of cured patients [ Time Frame: Recruiting Medium
placebo-controlled pilot-study. 2 weeks ]
Hydroxychloroquine
Estimated Primary
Sulfate
N=50 covid-19 patients with Completion Date:
pneumonia, age > 18. August 1, 2020
Ivermectin can inhibit
replication of SARS-CoV-2
Randomized to Ivermectin
in vitro
(12mg/weekly) + Hydroxychloroquin
Sponsor: University of
(400mg/daily) or placebo +
Baghdad
Hydroxychloroquin (400mg/daily)
Ivermectin and NCT04360356 Egypt Phase 2/3, randomized, double-blinded Number of Patients with COVID-19- Not yet recruiting Medium
Nitazoxanide trial evaluating safety and efficacy of negative PCR [ Time Frame: within 10
Ivermectin and Nitazoxanide days ] Estimated Primary
Sponsor: combination as adjuvant therapy in Completion Date:
Tanta University COVID-19 newly diagnosed Egyptian October 2020
patients.
N=100 adult symptomatic covid-19
patients randomized to
Ivermectin+Nitazoxanide or standard
care.
Ivermectin 2020-001474-29 Spain Phase 2, randomized, placebo- Proportion of patients with a positive Ongoing Medium
controlled, double-blind pilot study to SARS-CoV-2 PCR from a nasopharyngeal
Sponsor: determine the efficacy of a single dose swab [Time frame: day 7 post Estimated primary
Clínica Universidad de of ivermectin, administered to low risk, treatment] completion: 2020-06-
Navarra/Universidad de non-severe COVID-19 patients in the 15
Navarra first 48 hours after symptoms onset to
reduce the proportion of patients with
detectable SARS-CoV-2 RNA by PCR
from nasopharyngeal swab at day seven
post-treatment.
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N=266 randomized to Ivermectin or Incidence of secondary cases diagnosed
placebo. by molecular biology and serology on
the 7th, 14th, 21st day after starting
Sub-study 1 (to demonstrate the prophylaxis with Ivermectin and with
Efficacy of Ivermectin in the treatment placebo
of SARS-CoV-2): Symptomatic
(respiratory) patients with a positive
PCR-RT test for COVID-19 and a clinical
condition of less than 5 days of
evolution.
Ivermectin NCT04405843 Not stated Phase 2/3 Randomized, Placebo Time to event [ Time Frame: 21 days ]: Not yet recruiting Medium
Controlled, Double Blind Clinical Trial to Time until deterioration of 2 or more
Sponsor: Centro de Evaluate the Efficacy of Molecule points in an ordinal 7 points scale. Estimated Primary
Estudios en Infectogía D11AX22 in Adults Patients From Cali, Completion Date:
Pediatrica Colombia With Early Stages of SARS October 2020
COV2 / COVID-19.
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Alone in Patients With COVID-19
Infection.
Ivermectin NCT04407507 Not stated Phase 2, Multicenter, Double-blind, Participants with a disease control Not yet recruiting Medium
Randomized, Placebo-controlled Study status defined as no disease
Sponsor: SILVERBULLET to evaluate the efficacy, safety and progression to severe. [ Time Frame: 14 Estimated Primary
Investigacion Biomedica tolerability of Ivermectin in patients days ] Completion Date:
para el Desarrollo de with mild SARS-CoV-2 infection August 2020
Farmacos S.A. de C.V.
N=66 patients with diagnosis of acute
severe respiratory syndrome due to
covid-19, asymptomatic or mild
symptoms, randomized to Ivermectin or
placebo.
Ivermectin, Doxycycine, NCT04403555 Egypt Phase 2/3, randomized, open-label The number of patients with resolved Not yet recruiting Low
Chloroquine study to assess the efficacy of viral infection [ Time Frame: 6 months ]
Ivermectin and Doxycycline in COVID-19 Estimated Primary
Sponsor: Treatment Completion Date:
Tanta University December 1, 2030
N=40 COVID-19 patients randomized to
Ivermectin and doxycycline or
chloroquine
Ivermectin NCT04392713 Pakistan Open-label, controlled, randomized trial Negative PCR [Time Frame: 144 hours] Recruiting Low
on the Efficacy of Ivermectin in COVID-
Sponsor: Combined 19 Estimated Primary
Military Hospital, Pakistan Completion: July 2020
N = 100, age 15-65 with confirmed mild
to moderate Covid-19 infection,
rendomized to Ivermectin 6 MG oral
tablet with standard chloroquine
regimen or chloroquine only
Bicalutamide, Ivermectin NCT04374279 United States, Phase 2, open-label, controlled, Number of participants who have Not yet recruiting Low
Maryland randomized study on the use of clinical improvement at day 7 after
Sponsor: Sidney Kimmel Ivermectin or endocrine therapy in randomization [Time Frame: up to 7 Estimated Study
Comprehensive Cancer Covid-19 infection days] Completion: June
Center at Johns Hopkins 2021
N = 60, hospitalized with Covid-19 with
minimal or no respiratory symptoms
randomized 1:1:1 to
Bicalutamide + standard of care
Only Ivermectin
Only standard of care
Ivermectin NCT04351347 Egypt Open label, randomized controlled trial. Number of patients with virological cure Not yet recruiting; Low
N=60 patients with COVID-19 [ Time Frame: 6 months ] Estimated Primary
Sponsor: randomised to Chloroquine, Completion:
Tanta University December 1, 2030?
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Chloroquine + nitazoxanide, or
Chloroquine + ivermectin
Ivermectin NCT04390022 Spain Phase 2, double-blind, randomized Proportion of patients with a positive Not yet recruiting Low
controlled trial with two parallel groups SARS-CoV-2 PCR from a nasopharyngeal
Sponsor: SAINT that evaluates the efficacy of ivermectin swab [ Time Frame: 7 days post- Estimated Primary
Clinica Universidad de in reducing nasal viral carriage at seven treatment ] Completion Date:
Navarra, Universidad de days after treatment in SARS-CoV-2 August 4, 2020
Navarra infected patients who are at low risk of
progression to severe disease.
Control group.
Ivermectin NCT04373824 Non-randomized, open-label trial to Effect of Ivermectin on eradication of Recruiting Low
study the effectiveness of Ivermectin virus. [ Time Frame: 3 months ]
Sponsor: with standard of care vs. standard of Test for virus at 1, 3 & 5 days from Estimated Study
Max Healthcare Insititute care for COVID 19 cases. beginning of trial drug started for the Completion Date: July
Limited patient in the hospital 25, 2020
N=50 adult COVID-19 patients.
Group I (n=25): Ivermectin 200 to 400
mcg per kg body weight on day 1 and
day 2 along with standard treatment of
the hospital protocol.
Group II (n=25): standard treatment as
per hospital protocol for COVID 19.
Levamisole and NCT04360122 Egypt Phase 3, randomized, open labelled, Decrease the incidence of COVID-19 Not yet recruiting Medium
clinical trial to evaluate to tmpact of infection or its severity [ Time Frame: 6
Isoprinosine Levamisole and Isoprinosine in months ]
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Immune-prophylaxis of Egyptian Estimated Primary
Sponsor: healthcare workers facing COVID-19. Completion Date:
Ain Shams University October 1, 2020
N=100 healt care workers randomized
to Levamisole or Isoprinosine or
Levamisole+Isoprinosine or no
intervention.
Levamisole + Isoprinosine NCT04383717 Egypt Phase 3, Double-blinded, controlled, 1. COVID 19 induced fever in both Not yet recruiting Low
(and Azithromycin + randomized trial on the use of groups
Hydroxychloroquine) Levamisole and Isoprinosine in the 2. COVID 19 induced dyspnea in both Estimated Primary
Treatment of COVID19 groups Completion Date,
Sponsor: Cairo University 3. COVID 19 viral load in both groups August 30, 2020
Mefloquine NCT04347031 Russia, Moscow Phase 2, open-label, randomized trial The period of clinical recovery. [Time Enrolling by invitation Medium
on the efficacy of Mefloquine in Frame: through study completion, an
comparison with Hydroxychloroquine average of 3 months] Estimated Primary
Sponsor: Burnasyan
for patients with Covid-19 infection. Completion Date:
Federal Medical
For arm 1 and 2: The number of August 1, 2020
Biophysical Center
N=320, age > 18, hospitalized with patients with development of
Cvoid-19 infection respiratory failure requiring transfer to
the ICU [Time Frame: up to 3 months]
Arm 1: Mefloquine
Arm 2: Hydroxychloroquine For arm 3 and 4: Frequency of fatal
Arm 3: Mefloquine + azithromycin + / - outcomes associated with coronavirus
tocilizumab infection disease (COVID19) [Time
Arm 4: Hydroxychloroquine + Frame: through study completion, an
azithromycin + / - tocilizumab average of 3 months]
Niclosamide NCT04399356 Not stated Phase 2, randomized, double-blinded, Change in respiratory viral clearance (by Not yet recruiting High
placebo-controlled trial to evaluate the PCR), Oropharangeal swab [ Time
STUDY00000605 antihelmintic drug, Niclosamide, as a Frame: Day 3 and 10 ] Estimated Primary
Sponsor: potential treatment for mild to Completion Date:
Tufts Medical Center moderate coronavirus disease 2019 October 1, 2020
(COVID-19).
194
Version of 16.06.2020
Sponsor: evaluate the efficacy and safety of COVID-19 identified after start of Estimated Primary
Romark Laboratories L.C. Nitazoxanide (NTZ) for pre- or post treatment and before the end of the 6- Completion Date:
exposure prophylaxis of COVID-19 and week treatment period. [ Time Frame: August 31, 2020
other viral respiratory illnesses (VRI) in Up to 6 weeks ]
healthcare workers.
2. The proportion of subjects with
N=800 healthcare workers at increased symptomatic laboratory-confirmed VRI
risk for direct occupational exposure to identified after the start of treatment
COVID-19 randomized to Nitazoxanide and before the end of the 6-week
or placebo. treatment period. [ Time Frame: Up to 6
weeks ]
Nitazoxanide NCT04348409 Brazil Proof of Concept, Multicentre, Parallel, Viral load [Time Frame: day 1, 4, 7, 14 Recruiting Medium
Randomized, Double-blind Clinical Trial and 21]
Sponsor: Azidus Brasil to Assess the Safety and Efficacy of Estimated primay
Nitazoxanide compared to placebo. Completion Date: May
31, 2020
N = 50 patients age > 18 PCR confirmed
COVID-19 will receive nitazoxanide 600
mg BID for 7 days or placebo.
Nitazoxanide (NTZ) NCT04343248 Not stated Phase 3, multicenter, randomized, 1. Symptomatic laboratory-confirmed Not yet recruiting Medium
double-blind, placebo-controlled trial to COVID-19 [ Time Frame: up to 6 weeks ]
A synthetic evaluate the efficacy and safety of NTZ Estimated Primary
antiprotozoal agent for post-exposure prophylaxis of COVID- 2. Symptomatic laboratory-confirmed Completion Date:
19. viral respiratory infection [ Time Frame: August 31, 2020
Sponsor: Romark up to 6 weeks ]
Laboratories L.C. N=600 residents of LTCFs at least 65
years of age randomized to
nitazoxanide or placebo.
Nitazoxanide, Ribavirin NCT04392427 Egypt Phase 3, randomized, sequential clinical Negative test result for COVID-19 [ Time Not yet recruiting Medium
and Ivermectin trial to compare the rate and time of Frame: 2 YEARS ]
viral clearance in subjects receiving the Estimated Primary
Sponsor: Mansoura combination of Nitazoxanide, Ribavirin Completion Date: May
University and Ivermectin vs. those control group 2022
(without any intervention).
195
Version of 16.06.2020
N=150 health workers with symptoms
of SARS-CoV-2 not requiring
hospitalization will receive an early
treatment with nitazoxanide (500 mg
every 6 hour for two days and then
every 12 hours for four days).
Nitazoxanide, Ivermectin, NCT04382846 Not stated Phase 3, randomized, open-label trial. Number of patients with virological cure Not yet recruiting Low
Chloroquine and [ Time Frame: 6 months ]
Azithromycin N=80 patients with COVID-19 infection Estimated Primary
randomized to Nitazoxanide + Completion Date:
Sponsor: Azithromycin OR Ivermectin + December 1, 2030
Tanta University chloroquine OR Ivermectin +
Nitazoxanide OR Nitazoxanide +
Ivermectin + Azithromycin
Suramin sodium ChiCTR2000030029 Zhejing, China Single arm study of 20 patients with Clinical cure rate, incidence of From2020-01-31 To Low
http://www.chictr.org.c covid-19. mechanical ventilation by day28; 2020-05-30
Used for treatment of
n/showproj.aspx?proj=4 All-cause mortality by day28;
trypanosomiasis
9824 Incidence of ICU admission by day28
Respiratory system
Product Study identifier Study location Study design Primary outcome Status of trial Importance
NCT04357457 France Phase 3, randomized controlled, Rate of endotracheal intubation [ Time Not yet recruiting High
Almitrine placebo-controlled, double-blind study Frame: 7 days ]
(AIRVM-COVID) to evaluate to efficacy of intravenous Estimated Study
Sponsor: Assistance Almitrine in reducing the need for Completion Date: July
Publique - Hôpitaux de mechanical ventilation. 2020
Paris
N = 212 patients with hypoxemic acute
respiratory failure due to covid-19-
related pneumonia
Almitrine bismesylate NCT04380727 France An observational, prospective, case- 1.Changes from baseline PaO2 (mmHg) Completed Low
control study to evaluate almitrine [ Time Frame: 45 minutes after
Sponsor: Central Hospital, compared to control group. almitrine infusion ] Actual Study
Nancy, France 2.Changes from baseline ScvO2 (%) [ Completion Date:
N = 17 severe COVID-19 patients in ICU Time Frame: baseline and 45 minutes April 25, 2020
after almitrine infusion ]
ChiCTR2000030328 Hubei, China Clinical trial, blinding not stated. Wide range of primary outcomes Not yet recruiting Low
Acetylcystein http://www.chictr.org.c N=60 with moderate covid-19 treated End-date not specified
Inhaled n/showproj.aspx?proj=5 with either
0241 Acetylcysteine inhaled via tracheal tube
or saline inhaled via tracheal tube
N-acetylcysteine NCT04374461 United States, Phase 2, open-label, non-randomized 1. Number of patient's that transfer Recruiting Low
New York study of N-acetylcysteine in Severe or out of critical care unit or
196
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Sponsor: Memorial Sloan Critically Ill Patients With Refractory extubation (Arm 1) [Time Frame: 1 Estimated Study
Kettering Cancer Center COVID-19 Infection year] Completion: May 2021
197
Version of 16.06.2020
hospitalised participants with COVID-
19.
198
Version of 16.06.2020
NCT04389671 Not stated Phase 1/2, multicenter, single- Oxygenation index (OI) area under the Not yet recruiting Low
Lucinactant treatment, open-label study to assess curve (AUC)0-12 [ Time Frame: 12 hours
02-CL-2001a the safety and preliminary efficacy of post initiation of dosing ] Estimated Primary
Sponsor: lyophilized Lucinactant. The AUC for OI through 12 hours Completion Date:
Windtree Therapeutics measured using the trapezoidal October 2020
N=30 adults with COVID-19 associated method, where OI is defined as mean
acute lung injury airway pressure (Paw)×fraction of
inspired oxygen (FiO2)×100/arterial
pressure of oxygen (PaO2)
NCT04389411 Canada Phase 2/3, double-blinded, placebo- Emergency Room Visits and Not yet recruiting High
Montelukast controlled, randomized trial on the use Hospitalizations [Time Frame: 12
of Montelukast for the Attenuation and weeks] Estimated Primary
Prophylaxis of Severe COVID-19 Completion: February
Sponsor: McGill University Symptoms 2021
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2.Incidence of adverse events [ Time Estimated Primary
N = 30 patients who are hospitalized Frame: Up to 6 hours ] Completion Date:
and require supplemental oxygen 3.Incidence of methemoglobinemia [ January 1, 2021
Time Frame: Up to 14 days ]
GLS-1200 NCT04408183 United States, Phase II randomized, placebo- 1. Evaluate the number of GLS-1200 Recruiting Medium
Pennsylvania controlled, double-blind study will topical nasal spray adverse events as
(nitrogen oxide) assess whether topical GLS-1200 assessed by CTCAE v5.0 [ Time Frame: 4 Estimated Primary
applied via nasal spray atomizer is well- weeks of treatment ] Completion Date:
Sponsor: tolerated and can reduce the incidence September 2020
GeneOne Life Science, Inc. of confirmed SARS-CoV-2 infection 2. Incidence of SARS-CoV-2 infection,
confirmed by PCR relative to treatment
N=225 adult healthcare professional group [ Time Frame: 4 weeks of
randomized 2:1 to GLS-1200 or placebo. treatment ]
Nitric Oxide NCT04383002 Not stated A phase 1, open-label, randomized COVID-19 PCR status at completion of Not yet recruiting Low
study to test whether high dose inhaled treatment (day 3) from tracheal
Sponsor: University Health nitric oxide is safe and can reverse virus aspirate [ Time Frame: 3 days ] Estimated Primary
Network, Toronto burden and respiratory failure Completion Date:
December 2020
N = 20 patients on mechanical
ventilation.
Nitric Oxide NCT04397692 United States, An open label, randomized, study to Time to deterioration [ Time Frame: 14 Not yet recruiting Low
Arkansas obtain information on the safety and Days ]
Sponsor: Beyond Air Ltd efficacy of 80 ppm Nitric Oxide given in Estimated Primary
addition to the standard of care of Completion Date:
patients with COVID-19 caused by August 24, 2020
SARS-CoV-2 compared to standard of
care only.
N = 20
Nitric Oxide Releasing NCT04337918 Not stated Open label, multi-center, prospective, Prevention Study: Not yet recruiting; Low
Solution randomized, controlled, phase II, swab positive COVID-19 or presentation Estimated Primary
parallel group trial. of clinical symptoms as measured by Completion: July 31,
Sponsor: N=200 healthcare Workers and fatigue with either fever >37.2 2020
Sanotize Research and Individuals at Risk of Infection (oral)and/or a persistent cough.
Development corp. randomized to nasal Nitric oxide Treatment Sub Study: hospitalization
releasing solution or no treatment. for COVID-19/flu-like symptoms and/or
Furthermore, in a substudy 10 COVID- needing oxygen therapy, BIPAP/CPAP,
19 positive volunteers will receive the intubation and mechanical ventilation
treatment. following enrollment.
Nitrogen oxide; NCT04305457 Xijing Hospital Phase 2 randomised open label trial Reduction in intubation and mechanical Not yet recruiting; Low
Massachusetts N=240 with mild covid-19 ventilation (time frame 28 days) Estimated primary
Sponsor: Massachusetts General Randomised to NO or no intervention completion
General Hospital Hospital date/study
Fondazione completion:April
IRCCS Ca' 2021/ April 2022
Granda,
200
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Ospedale
Maggiore
Policlinico
Nitrogen oxide; NCT04306393 Xijing Hospital Phase 2 randomised open label trial Change of arterial oxygenation at 48 Not yet recruiting; Low
Massachusetts N=200 with severe covid-19 hours from enrollment [ Time Frame: 48 Estimated primary
Sponsor: Massachusetts General randomised to NO or no intervention hours ] completion
General Hospital Hospital date/study
Fondazione completion:March
IRCCS Ca' 2021/ March 2022
Granda,
Ospedale
Maggiore
Policlinico
iNO (inhaled nitric oxide) NCT04358588 Not stated Compasionate use of pulsed, inhaled Not Applicable Available Low
Nitric Oxide (iNO) for the treatment of
Sponsor: Bellerophon patients with mild or moderate
coronavirus disease (COVID-19)
Nitrogen oxide; NCT04312243 Xijing Hospital Preventive study: Percentage of subjects with COVID-19 Not yet recruiting; Low
Massachusetts Phase 2 open label trial of 460 diagnosis Estimated primary
Sponsor: Massachusetts General healthcare workers. completion
General Hospital Hospital date/study
Fondazione completion:March
IRCCS Ca' 2021/ March 2022
Granda,
Ospedale
Maggiore
Policlinico
NaCl Solution NCT04382131 United Kingdom Randomised controlled, parallel group Time to resolution of symptoms as Not yet recruiting Medium
trial of hypertonic saline nasal irrigation defined by the single question 'how
and gargling (HSNIG) compared to unwell do you feel today. [Time Frame: Estimated Primary
Sponsor: University of
standard care in participants with Maximum of 14 days] Comletion Date: July
Edinburgh
clinically suspected or confirmed 31, 2020
COVID-19 being managed at home.
N = 405 randomized to NaCl Solution
prepared at home using water and salt.
NCT04319731 Not provided Phase 1 study Ventilator Free Days Recruiting Low
Nebulized Single arm study Duration of supplemental oxygen use
amniotic fluid N=10 Estimated primary
completion
Sponsor: University of
March 20, 2021
Utah
Oxygen-ozone NCT04366089 Italy (multiple Phase 2, randomized, single-blinded Delta in the number of patients Recruiting Medium
NCT04359095 sites) (outcomes assessor) trial to evaluate requiring orotracheal intubation despite Not yet recruiting
therapy, SivoMixx (dietary
Colombia the effectiveness of an ozone therapy- treatment [ Time Frame: 21 days ]
supplement),
based intervention (accompanied by 1. Mortality Estimated Study
Hydroxychloroquine,
supplementation with probiotics) in Completion Date:
azithromycin
containing the progression of COVID-19 December 31, 2020
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and in preventing the need for 2. Number of Participants with
Sponsor: hospitalization in intensive care units. Treatment Related Severe Adverse
Roberto Poscia MD, PhD, Events as Assessed by the NCORP
Azienda Policlinico N=152 randomized to Oxygen-ozone Guidance for Collection of Adverse
Umberto and probiotic (SivoMixx) + standard of Events Related to COVID-19 Infection
Hydroxychlororquine + care or standard of care only.
lopinavir/ritonavir or [Time Frame: Post-intervention at day
azithromycin In this study standard of care includes 28]
Azithromycin and hydroxychloroquine.
Sponsor: Universidad Phase 2/3, open-label, controlled,
Nacional de Colombia randomized trial on HCQ +
ritonavir/lopinavir or azithromycin vs
standard treatment
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Other
Product Study identifier Study location Study design Primary outcome Status of trial Importance
ABX464 NCT04393038 France Phase 2/3, randomized, double-blind, Rate of patients with no invasive or Recruiting High
placebo-controlled study to evaluate non-invasive mechanical ventilation
small molecule undergoing ABX464-401 the efficacy and safety of ABX464 in (IMV and NIV, respectively), but Estimated Primary
development for inhibiting treating inflammation and preventing excluding simple nasal/mask oxygen Completion Date:
HIV replication COVID-19 associated acute respiratory supplementation, and who are alive [ December 30, 2020
failure in patients aged ≥ 65 and Time Frame: at the end of the 28-day
Sponsor: aatients aged ≥18 with at least one treatment period ]
Abivax S.A. additional risk factor who are infected
with SARS-CoV-2.
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Version of 16.06.2020
antioxidative action used
in Russia N = 394 patients with coronavirus
disease
Sponsor: NPO Petrovax
Bactek-R NCT04363814 Not stated A phase 3, prospective, open-label, Clinical recovery [ Time Frame: 2 weeks Not yet recruiting Medium
randomized pilot study to evaluate the ]
Sponsor: Inmunotek S.L. efficacy and safety of BACTEK-R Estimated primary
(MV130) compared to control group Clinical worsening [ Time Frame: 2 Completion Date: July
(standard therapy). weeks ] 01, 2020
204
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designation by the FDA for
the treatment of DMD.
CMAB806 ChiCTR2000030196 Hubei, China Phase 2, a multicenter, single arm, open Relive of cytokine release syndrome Not yet recruiting; Low
http://www.chictr.org.c label trial From2020-02-20 To
n/showproj.aspx?proj=4 N=60 with moderate or severe covid-19 2020-05-31
9883 with elevated IL6
CM4620 NCT04345614 United States, Phase 2 randomized controlled parallel Improvement on a 7-point Ordinal Scale Recruiting Medium
Injectable Emulsion Minnesota + open-label Study of CM4620 Injectable [Time Frame: Upon enrollment into the
Michigan Emulsion in Patients With Severe study through hospital discharge, up to Estimated primary
CM4620-IE is a small COVID-19 Pneumonia day 28] completion July 2020
molecule CRAC channel
inhibitor that prevents
CRAC channel N = 120 age > 18 with PCR confirmed
overactivation, which can COVID-19 randomized to receive
cause pulmonary CM4620-IE 2.0 mg/kg on Day 1 and 1.6
endothelial damage and mg/kg on Days 2 and 3 or local standard
cytokine storm in COVID- care.
19.
Sponsor: CalciMedica, Inc Other Name: CM4620-IE
CytoSorb NCT04324528 Germany Open label randomized controlled trial. Interleukin-6 (IL-6) level after 72 hours Recruiting, Estimated Medium
Cytokine absorption N=30 critically ill patients randomized Primary Completion:
to ECMO +/- cytokine absorption September 26, 2020
Dalargin NCT04346693 Russia Open, randomized study of the 1.The change of viral load in patients Enrolling by invitation Low
stable leu-enkephalin effectiveness of the drug Dalargin for with SARS-COVID-19. [ Time Frame:
analog the prevention and treatment of Upon patient inclusion in the study, Estimated Primary
symptoms of pulmonary complications after 96 hours and on the 10day; ] Completion Date:
Sponsor: in patients with coronavirus infection December 2020
Burnasyan Federal Medical (SARS-COVID-19). 2.The frequency of development of
Biophysical Center Acute Respiratory Distress Syndrome
N=320 hospitalised patients (ADRS) [ Time Frame: up to 8 months ]
randomized to
Standard therapy, 3.Duration of hospitalization [ Time
Dalargin inhalation, Frame: through study completion, an
Dalargin intramuscular, or average of 8 months ]
Dalargin inhalation + intramuscular
injection 4.The frequency of early mortality [
Time Frame: up to 30 days ]
All patients will receive standard
therapy: Hydroxychloroquine + 5.The frequency of late mortality [ Time
azithromycin + / - tocilizumab. Frame: up to 90 days ]
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Version of 16.06.2020
DAS181 NCT04354389 Italy A Phase II/III, Multicenter, Randomized, COVID-19 Clinical Status Scale (CCSS) [ Not yet recruiting Medium
(multicenter) Placebo-Controlled, Double-Blind Study. Time Frame: Day 14 ]
DAS181 is a sialidase 2020-001874-30 Percent of subjects improved (1 to 7 Estimated Primary
fusion protein that cleaves N=82 subjects diagnosed with lower where higher score means worse Completion Date: June
both the Neu5Ac α(2,3)- respiratory tract COVID-19 who require outcome) 30, 2020
and Neu5Ac α(2,6)-Gal supplemental oxygen ≥2 LPM at the
linkages of sialic acid from time of randomization.
respiratory endothelial cell Randomized to DAS181+ standard local
surfaces. Has been tested care for COVID-19 or Placebo+ standard
in influenza and local care for COVID-19.
parainfluenza.
Two-staged design. N=22 subjects with
Sponsor: COVID-19 and clinically significant
Ansun Biopharma, Inc. impairment of respiratory function will
be enrolled and evaluated. If pre-
determined safety and efficacy
parameters are achieved, the study will
proceed to Stage 2 and expand
enrollment with an additional sixty
(n=60) subjects or more to provide
adequate power to potentially
demonstrate statistically significant
therapeutic efficacy.
Deferoxaminmesilat NCT04333550 Iran, Islamic Randomised trial. Mortality rate [ Time Frame: up to 20 Recruiting; Low
(Desferal) Republic of N=50 randomised to Deferoxamine or days ] Estimated Primary
iron chelator standard of care Completion:
September 2020
Desferal NCT04389801 Egypt ?? Phase 4, randomized, single-blinded Mortality rate [ Time Frame: two weeks Not yet recruiting Medium
(participant) trial to evaluate the ]
Sponsor: efficacy of using Desferal injections for Estimated Primary
Hesham Al-Inany prevention of ARDS in moderate covid- Completion Date:
19 cases with fever, chest tightness and September 30, 2020
relevant chest images.
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https://www.eurekalert.
org/pub_releases/2020-
04/uonc-ana040320.php
DFV890 NCT04382053 Multicenter Phase 2, open-label, multi-center, APACHE II severity of disease score on Not yet recruiting medium
controlled, randomized trial on the Day 15 or on the day of discharge
Sponsor: Novartis efficacy of DFV890 for the treatment of (whichever is earlier) [Time Frame: up Estimated Primary
Pharmaceuticals COVID-19 associated oneumonia and to Day 15] Completion Date: July
impaired respiratory function 29, 2020
207
Version of 16.06.2020
Sponsor: (SAEs) [ Time Frame: Continuous
BioAegis Therapeutics Inc. through Day 28 ]
Chlorine dioxide NCT04343742 Colombia, Case-only observational study on the Negative testing of COVID-19 [Time Recruiting Low
oral Bogota effectiveness of oral Chlorine Dioxide in frame: 7 days]
Sponsor: Genesis treatment of COVID-19 Estimated Primary
Foundation Completion Date:
N=20, with active COVID-19 infection April 7, 2020
DeltaRex-G NCT04378244 Not stated A phase 1/2, open-label single-group Maximum Tolerated Dose [ Time Not yet recruiting Low
study using deltarex-g gene therapy for Frame: 3 weeks ]
(a non-pathogenic, symptomatic COVID-19 Estimated Primary
replication incompetent, Completion Date:
RNA virus-based gene N = 18 January 12, 2021
vector. Can mimic RNA
virus SARS-CoV-2 by
binding to viral receptors
in human cells and may
serve as a decoy to
prevent SARSCoV-2 cell
entry by crowding/
neutralizing the SARS-CoV-
2 even where the
receptors may be
different)
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IMU-838 NCT04379271 Not stated A phase 2/3, randomized, placebo- Proportion of patients without any Not yet recruiting High
controlled, double-blinded study to need* for INV until end-of-study (EoS) [
(By inhibiting evaluate the efficacy, safety and Time Frame: Throughout the Study (Day Estimated Primary
dihydroorotate tolerability of IMU-838 as addition to 0 to Day 28) ] Completion Date:
dehydrogenase (DHODH), investigator's choice of standard of care October 2020
a key enzyme of therapy
pyrimidine de novo
biosynthesis, metabolically N = 600 patients with coronavirus
activated T and B immune disease 19
cells experience metabolic
stress, and the release of
Th1 and Th17 key
cytokines including IL-17A,
IL-17F and IFNg is
inhibited). Not licensed.
Under investigation for
RRMS, inflammatory bowl
disease and other chronic
inflammatory and
autoimmune diseases.
Sponsor: Immunic AG
Aerosolized 13 cis retinoic NCT04396067 Egypt Phase 2, open-label, placebo- Lung injury score (time frame: 7 days) Not yet recruiting Low
acid (Isotretinoin) controlled, randomized trial.
Estimated Primary
Sponsor: Kafrelsheikh N = 360, adult SARI patients with Covid- Completion:
University 19 infection receiving mechanical September 2020
ventilation
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Sponsor: Institut de N = 180 patients who experience severe Estimated Primary
Cancerologie Strasbourg acute respiratory distress syndrome Completion Date: July
Europe (ARDS) and are receiving artificial 31, 2020
respiratory support due to COVID-19
Levamisole + budesonide + NCT04331470 Not stated Open label, randomized controlled trial. Clear chest CT-scan and PCR test [ Time Recruiting; Low
formoterol N=30 patints with COVID -19 Frame: between 3-7 days ] Estimated Primary
Sponsor: Fasa University of randomised to Completion: April 20,
Medical Sciences Levamisole + budesonide + formoterol 2020
+ Lopinavir+Ritonavir +
Hydroxychloroqine, or
Lopinavir+Ritonavir +
Hydroxychloroqine
LSALT Peptide NCT04402957 Not stated Phase 2, Multicenter, Randomized, Development of Acute Respiratory Not yet recruiting High
Double-Blind, Placebo-Controlled, Proof Distress Syndrome (ARDS) and Other
(DPEP-1 inhibitor) of Concept Trial of LSALT Peptide as Organ Injuries [ Time Frame: 28 days ] Estimated Primary
Prevention of Acute Respiratory Completion Date:
Sponsor: Distress Syndrome (ARDS) and Other December 31, 2020
Arch Biopartners Inc. Organ Injuries in Patients Infected With
SARS-CoV-2
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MCN NCT04370288 Iran Phase 1, randomized, single-blinded Proportion of patients remaining free of Recruiting Low
(Methylene blue, vitamin (outcomes assessor) need for mechanical ventilation in both
C, N-acetyl cysteine) groups [ Time Frame: Day 7 ] Estimated Study
N=20 covid-19 positiv subjects with Completion Date:
Sponsor: need for intubation and mechanical September 21, 2020
Mashhad University of ventilation randomized to MCN
Medical Sciences (Methylene blue, vitamin C, N-acetyl
cysteine) or standard medical therapy.
Mycobacterium w NCT04347174 Chandigarh, Randomised, blinded, two arms, active Sequential Organ Failure Assessment Not yet recruiting Low
(autoclaved) India comparator controlled, parallel (SOFA) scores day 3, day 7, day 14, day
Sponsor: assignment 21, day 28 Estimated study start:
Cadila Pharmaceuticals Apr 20, 2020
Treatment of critically ill COVID-19
patients Estimated primary
completion data:
N: 40 Jun 30, 2020
18 years and older
Mycobacterium w NCT04353518 India Phase 3, double-blinded, placebo- Number of subject acquiring COVID-19 Not yet recruiting High
controlled, randomized trial on the infection [Time Frame: From first dosing
Sponsor: Cadila efficacy of autoclaved Mycobacterium to week 1, week 2, week 4, week 8 or at Estimated Primary
Pharnmaceuticals w in preventing Covid-19 infection any time during the study till 8 week Completion Date,
post first dosing.] March 30, 2021
N = 4000, age >17, with recent history
of close contact with Covid-19 patients
Mycobacterium w NCT04358809 India Randomized, double-blinded, two arms, Number of patients with increased Not yet recruiting Medium
(autoclaved) placebo controlled, clinical trial. disease severity [ Time Frame: From
N=480 randomised to mycobacterium baseline to Day 3, Day 7, Day 14, Day Estimated Study
Sponsor: Cadila W or placebo 21, Day 28 or at any time during the Completion Date:
Pharnmaceuticals study till 28 days post first dosing. ] April 30, 2021
N-803 NCT04385849 Not stated A phase 1b, randomized, blinded, 1.Preliminary safety and efficacy Not yet recruiting Medium
placebo-controlled study to assess the evaluation of N-803 by adverse event
An interleukin-15 (IL-15) safety and immunostimulatory activity (AE) incidence [ Time Frame: 2 weeks ] Estimated Primary
superagonist complex in of N-803. 2.Preliminary safety and efficacy Completion Date: July
combination with Bacillus evaluation of N-803 by subject clinical 11, 2020
Calmette-Guerin N = 30 adult subjects with COVID-19. status using a the 7-point ordinal scale.
Sponsor: ImmunityBio, Inc. [ Time Frame: 2 weeks ]
NT-17 NCT04380948 United States, A phase 1, randomized, double-blind, Change in absolute lymphocyte count Not yet recruiting Medium
Missouri placebo-controlled pilot study (ALC) [ Time Frame: From baseline to
(Long Acting Interleukin-7) evaluating the effect of NT-I7 to Day 14 ] Estimated Primary
enhance immune clearance of SARS- Completion Date:
Sponsor: Washington CoV-2 February 28, 2021
University School of
Medicine N = 30 COVID-19 patients without
severe disease will be randomized on a
2:1 basis to receive NT-I7 or placebo.
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OrganicellTM Flow NCT04384445 United States, Phase 1/2, randomized, parallel design, To demonstrate the safety of Not yet recruiting Low
Sponsor: Georgia double-blinded trial to evaluate the OrganicellTM Flow administered Estimated Primary
Organicell Regenerative safety and potential efficacy of i.v. intravenously in patients with severe Completion Date:
Medicine infusion of OrganicellTM Flow for the acute respiratory syndrome (SARS) September 30, 2020
treatment of moderate to severe SARS related to COVID-19 infection. [ Time
related to COVID-19 infection vs. Frame: Day 60 ]
placebo.
N=20 randomized 1:1 to OrganicellTM
Flow + standard of care or placebo +
standard of care.
Ozone therapy NCT04359303 Spain A phase 3, double-blinded, randomized COVID19 clinical scale [ Time Frame: Not yet recruiting Medium
control trial to evaluate the safety and through study completion, an average
Sponsor: Javier Hidalgo (OzonoCOVID19) efficacy of indirect endovenous ezone of 3 weeks ] Estimated Study
Tallón therapy. Completion Date: June
2020
N = 50 non-intubated patients
randomized to control or treatment
group
Ozone Auto-hemotherapy NCT04370223 Spain Phase 3, open-label, controlled, Rate of patients achieving improvement Not yet recruiting Low
randomized trial on the use of ozone in clinical condition at day 14 after
Sponsor: Institut Multicenter auto-hemotherapy in hopsitalized recruitment [Time Frame: 14 days] Estimated Study
d'Investigació Biomèdica patients with Covid-19 Completion Date:
de Girona Dr. Josep Trueta December 25, 2020
N = 208, age 18-90, hsopitalized with
Covid-19 and pneumonia randomized
to ozone auto-hemotherapy (mixing
100-200ml of blood with ozone every
12h during 5 days)
+ standard treatment or standard
treatment alone
Ozone Therapy NCT04400006 Turkey Case-only Prospective study of the Survey taken by telephone calls: It Completed Low
prophylactic effect of at least ten involved questions about age, gender, Date: May 17, 2020
Sponsor: Marmara sessions of ozone therapy. height, weight, occupation,
University N=71 comorbidities, and concurrent
medications, in addition to a detailed
query for COVID-19 infection.
PH94B NCT04404192 United States, Phase 2, single-arm, open-label study Hamilton Anxiety Scale [ Time Frame: Not yet recruiting Low
New York of the efficacy and safety of PRN PH94B 14 days ]
Under development for Neuroactive Nasal Spray in the Estimated Primary
Social Anxiety Disorder. Treatment of Adjustment Disorder With Completion Date: July
Anxiety (AjDA) Associated With COVID- 2021
Sponsor: 19
VistaGen Therapeutics,
Inc. N=30 with diagnosis of Adjustment
Disorder with Anxiety (AjDA)
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Ved ikke hvor relevant dette studie er –
positiv covid-19 er et eksklusionskriterie
Povidone-Iodine NCT04347954 United States, Randomised, double-blind controlled Mean change in viral titers of SARS- Not yet recruiting; Medium
California trial. CoV-2 [ Time Frame: Baseline, Day 3, Estimated Primary
Sponsor: N=45 subjects Positive test for COVID- Day 6, and Day 9 ] Completion: July 2020
Stanford University 19 within two days of enrollment
randomised to
Povidone-Iodine 2%,
Povidone-Iodine 0.5%, or
Isotonic saline 0.9%
Povidone-Iodine NCT04393792 United Kingdom A phase 1, open-label, randomized trial Change in viral load in the oral and Recruiting Low
to evaluate if sinus rinse and mouth nasopharyngeal cavity [ Time Frame:
Sponsor: Hampshire wash reduce viral load. Day 0, 2, 3, 7, 14 ] Estimated Primary
Hospitals NHS Foundation Completion Date:
Trust N = 40 COVID-19 positive individuals August 2020
and their co-residents. Parallel group
design with 1:1 randomised allocation
to treatment or control
Povidone/ Iodine NCT04344236 United States, Phase 2, randomized, controlled, open Viral load (and/or cycle time to PCR as a Recruiting Low
New York label, parallel design, single site study. proxy for quantitative viral load) in the
vs Chlorhexidine oral/nasal nasopharynx and oropharynx [ Time Estimated Primary
rinse N=48 COVID-19 positive patients Frame: 7 days ] Completion Date:
Saline oral/nasal rinse randomized to Saline oral/nasal rinse or May 1, 2020
0.5% Povidone/Iodine oral/nasal rinse
Sponsor: or 0.12% Chlorhexidine oral/nasal rinse
NYU Langone Health or nothing (control group).
Patients will then be tested for COVID-
19 once daily in the evening for 7 days
and viral loads will be measured.
Povidone-iodine (PVP-I) NCT04364802 United States, A phase 2, non-randomized, open-label 1.Percent of healthcare workers testing Not yet recruiting Low
Kentucky trial evaluate the efficacy of PVP-I as positive for COVID-19. [ Time Frame: 3
Sponsor: Alexandra Kejner prophylaxis in Coronavirus Disease 2019 weeks ] Estimated Study
(COVID19)-negative front-line health Completion Date: May
care workers and hospital patients 2.Percent of patients testing positive for 2021
compared to control group. COVID-9. [ Time Frame: 2 weeks ]
N = 250
Povidone-Iodine NCT04371965 France A phase 2, randomized controlled open Change from baseline naso-pharyngeal Not yet recruiting Low
label trial to reduce naso- pharyngeal viral load quantified by RT-PCR at Day7 [
Sponsor: Poitiers viral load. Time Frame: Day 7 ] Estimated Study
University Hospital Completion Date: July
N = 24 patients with positive 1, 2020
nasopharyngeal SARS-CoV-2 carriage
will be randomized (1:1) in an
experimental group or a control group.
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Prolastin 2020-001953-36 Spain Phase 2, multicenter, randomized, The primary efficacy variable is the Ongoing Medium
open-label, parallel group, pilot study to proportion of subjects dying or
Sponsor: evaluate the safety and efficacy of requiring ICU admission on or before Estimated primary
Instituto Grifols, S.A Prolastin in hospitalized subjects with Day 15 or who are dependent on completion: 2020-06-
COVID-19. invasive mechanical ventilation on Day 07
15.
N=100 randomized to Prolastin +
standard medical treatment or standard
medical treatment alone.
Alpha one antitrypsin NCT04385836 Saudi Arabia An early phase 1, randomized, single Clinical improvement [ Time Frame: we Recruiting Medium
inhalation blinded trial of alpha one antitrypsin will follow the patient daily starting
inhalation from the day 0 which is the first day of Estimated Primary
Sponsor: Ministry of giving drug for 3 weeks or till clinical Completion Date:
Health, Saudi Arabia N = 150 patient with severe acute improvement and discharge from the September 1, 2020
respiratory syndrome coronavirus 2 hospital or till death whichever comes
(SARS-CoV-2) first. ]
PUL-042 NCT04313023 Not yet A Phase 2 Multiple Dose, Double Prevention of COVID-19 [ Time Frame: Not yet recruiting. High
Toll like receptor 2/6/9 provided blinded, placebo-controlled study. 14 days ]
Agonist N=200 exposed patients (without Estimated Study
In a phase 2 study in stem COVID-19) randomised to Completion:
cell transplant recipients. PUL-042 or placebo Septtember 1 2020
Sponsor: Pulmotect, Inc.
PUL-042. NCT04312997 Houston, Texas, A Phase 2 Multiple Dose Double Ordinal Scale for Clinical Improvement Not yet recruiting. High
Toll like receptor 2/6/9 US blinded, placebo controlled study. (score 1-8) [ Time Frame: 14 days ]
Agonist N=100 with COVID-19 without severe Estimated primary
In a phase 2 study in stem symptoms randomised to Completion:
cell transplant recipients. PUL-042 or placebo September 2020
Sponsor: Pulmotect, Inc.
RBT-9 NCT04364763 Not stated A phase 2, randomized, single-blinded, Evaluate the effect of RBT-9(stannous Not yet recruiting Medium
(Stannous protoporphyrin) placebo-controlled study to evaluate protoporphyrin) versus placebo on
the effect of RBT-9 on preventing clinical status of Covid-19 patients as Estimated Study
Sponsor: Renibus progression of COVID-19 measured using the 8-point World Completion Date:
Therapuetics, Inc. Health Organization (WHO) Ordinal December 31, 2021
N = 252 non-critically ill adults who are Clinical Scale [ Time Frame: 28 days ]
at high risk due to age or comorbid
conditions randomly assigned in a 2:1
ratio to receive Stannous
protoporphyrin or placebo (normal
saline).
Resveratrol + vitamin D3 NCT04400890 Not stated Phase 2, randomized double-blind Hospitalization rates for COVID-19 [ Not yet recruiting Medium
placebo-controlled proof-of-concept Time Frame: 21 days from testing
Sponsor: McCreary2020 trial of Resveratrol for the outpatient positive from COVID-19 ] Estimated Primary
Marvin McCreary, MD, treatment of mild COVID-19. Completion Date:
Mount Carmel Health September 2020
System N=200, Age ≥45 years
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Randomized 1:1 to Resveratrol +
vitamin D3 or placebo + vitamin D3.
Saline Nasal Irrigation NCT04347538 United States, Randomized, Open-label trial to 1.Change in SARS-CoV-2 mucosal Not yet recruiting Low
Tennessee evaluate the impact of Nasal Saline immune response in the nasopharynx [
Sponsor: Irrigations on Viral Load in Patients Time Frame: Day 1 to day 21 ] Estimated Primary
Vanderbilt University With COVID-19. Completion Date: June
Medical Center 2.Change in microbial load in the 2021
N=90 randomized to one of three nasopharynx [ Time Frame: Day 1 to day
treatment groups: 21 ]
1. Control - no intervention
2. intervention 1 - nasal saline 3.Change in Viral Load in the
irrigations BID 3. intervention 2 - nasal nasopharynx over the course of COVID-
saline irrigations with ½ teaspoon 19 infection [ Time Frame: Day 1 to day
surfactant (Johnson's baby shampoo) 21 ]
BID).
Bovine Lipid Extract NCT04375735 Not stated A phase 1/2 randomized, open label 1.Adverse events (patient) - Decrease in Not yet recruiting Low
Surfactant trial to determine feasibility and safety oxygenation
of bovine lipid extract surfactant. 2.Adverse events (patient) - Decrease in Estimated Primary
Sponsor: Lawson Health hemodynamics Completion Date:
Research Institute N = 20 COVID-19 positive patients and 3.Adverse event (healthcare worker) - January 1, 2021
require MV due to progressive Circuit breach
respiratory failure will be randomized 4.Adverse event (healthcare worker) -
to receive either 1) exogenous COVID-19 symptoms
surfactant (BLES) or 2) treatment as
usual
Senicapoc Eudract: 2020-001420- Denmark Randomized, Open-Label, Phase II Trial PaO2/FiO2 ratio 72 hours after Ongoing Medium
A Gardos channel blocker. 34 N= 46 with covid-19 admitted to ICU randomization.
randomized to senicapoc or standard
treatment
Sn-protoporphyrin IX NCT04371822 Egypt? Phase 1, non-randomized, open-label Lung injury score [ Time Frame: at 7and Not yet recruiting Low
(SnPPIX) and sulfonated trial 14 days
tetranaphthyl porphyrin Estimated Study
N=56 (28 covid-19 positive patients and Completion Date:
Sponsor: 28 healthy vulenteers) divided into 8 August 2020
Kafrelsheikh University equal groups:
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administered a single dose of 9 mg, 27
mg or 90 mg Stannous Protoporphyrin +
CT chest scan.
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Ulinastatin ChiCTR2000030806 China, Hubei Phase 1, retrospective, observational - Blood RT Recruiting Low
+ Oral Chinese medicine study for the efficacy of ulinastatin - ABG
"qingfei detoxification combined with ''clear lung Study execute time:
soup" detoxification soup'' in the treatment of [Time frame: Before treatment, 3 days, 2020-02-01 to 2020-
novel coronavirus pneumonia (COVID- 6 days and 9 days after medication] 03-31
Sponsor: 19).
Wuhan Third Hospital
N=20
Link to WHO´s list of studies for the treatment of COVID-19, updated March 21st 2020:
https://www.who.int/blueprint/priority-diseases/key-action/Table_of_therapeutics_Appendix_17022020.pdf?ua=1
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